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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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SCOTT'S SELECT MICROHYBRID SYRINGE 4.5 Gm (B1) - D77819920120

Scott’s Select Microhybrid Composite is indicated for direct aesthetic restoration of anterior and posterior teeth and can be used in limited occlusal function. Microhybrid Composite is a light activated, resin based dental restorative material. Microhybrid Composite consists of approximately 75wt% (54vol%) silanated 0.7 micron Barium glass and 0.01 micron silica, approximately 25wt$ Bis-GMA based dimethacrylate system, and approximately 1wt% catalysts, inhibitors and pigments. Shade/color: B1. Instructions for use and SDS available at https://www.scottsdental.com/microhybrid-composite-syringe-scott-s-select.html.
SCOTT'S DENTAL SUPPLY L.L.C.
199-2012
In Commercial Distribution

  • D77819920120 ()

  • Weight: 4.5 Gram
199-2012

  • Dental composite resin

SCOTT'S SELECT MICROHYBRID SYRINGE 4.5 Gm (A4) - D77819920110

Scott’s Select Microhybrid Composite is indicated for direct aesthetic restoration of anterior and posterior teeth and can be used in limited occlusal function. Microhybrid Composite is a light activated, resin based dental restorative material. Microhybrid Composite consists of approximately 75wt% (54vol%) silanated 0.7 micron Barium glass and 0.01 micron silica, approximately 25wt$ Bis-GMA based dimethacrylate system, and approximately 1wt% catalysts, inhibitors and pigments. Shade/color: A4. Instructions for use and SDS available at https://www.scottsdental.com/microhybrid-composite-syringe-scott-s-select.html.
SCOTT'S DENTAL SUPPLY L.L.C.
199-2011
In Commercial Distribution

  • D77819920110 ()

  • Weight: 4.5 Gram
199-2011

  • Dental composite resin

SCOTT'S SELECT MICROHYBRID SYRINGE 4.5 Gm (OPAQUE) - D77819920100

Scott’s Select Microhybrid Composite is indicated for direct aesthetic restoration of anterior and posterior teeth and can be used in limited occlusal function. Microhybrid Composite is a light activated, resin based dental restorative material. Microhybrid Composite consists of approximately 75wt% (54vol%) silanated 0.7 micron Barium glass and 0.01 micron silica, approximately 25wt$ Bis-GMA based dimethacrylate system, and approximately 1wt% catalysts, inhibitors and pigments. Shade/color: Opaque. Instructions for use and SDS available at https://www.scottsdental.com/microhybrid-composite-syringe-scott-s-select.html.
SCOTT'S DENTAL SUPPLY L.L.C.
199-2010
In Commercial Distribution

  • D77819920100 ()

  • Weight: 4.5 Gram
199-2010

  • Dental composite resin

SCOTT'S SELECT MICROHYBRID SYRINGE 4.5 Gm (D4) - D77819920090

Scott’s Select Microhybrid Composite is indicated for direct aesthetic restoration of anterior and posterior teeth and can be used in limited occlusal function. Microhybrid Composite is a light activated, resin based dental restorative material. Microhybrid Composite consists of approximately 75wt% (54vol%) silanated 0.7 micron Barium glass and 0.01 micron silica, approximately 25wt$ Bis-GMA based dimethacrylate system, and approximately 1wt% catalysts, inhibitors and pigments. Shade/color: D4. Instructions for use and SDS available at https://www.scottsdental.com/microhybrid-composite-syringe-scott-s-select.html.
SCOTT'S DENTAL SUPPLY L.L.C.
199-2009
In Commercial Distribution

  • D77819920090 ()

  • Weight: 4.5 Gram
199-2009

  • Dental composite resin

SCOTT'S SELECT MICROHYBRID SYRINGE 4.5 Gm (C3) - D77819920080

Scott’s Select Microhybrid Composite is indicated for direct aesthetic restoration of anterior and posterior teeth and can be used in limited occlusal function. Microhybrid Composite is a light activated, resin based dental restorative material. Microhybrid Composite consists of approximately 75wt% (54vol%) silanated 0.7 micron Barium glass and 0.01 micron silica, approximately 25wt$ Bis-GMA based dimethacrylate system, and approximately 1wt% catalysts, inhibitors and pigments. Shade/color: C3. Instructions for use and SDS available at https://www.scottsdental.com/microhybrid-composite-syringe-scott-s-select.html.
SCOTT'S DENTAL SUPPLY L.L.C.
199-2008
In Commercial Distribution

  • D77819920080 ()

  • Weight: 4.5 Gram
199-2008

  • Dental composite resin

SCOTT'S SELECT MICROHYBRID SYRINGE 4.5 Gm (C1) - D77819920070

Scott’s Select Microhybrid Composite is indicated for direct aesthetic restoration of anterior and posterior teeth and can be used in limited occlusal function. Microhybrid Composite is a light activated, resin based dental restorative material. Microhybrid Composite consists of approximately 75wt% (54vol%) silanated 0.7 micron Barium glass and 0.01 micron silica, approximately 25wt$ Bis-GMA based dimethacrylate system, and approximately 1wt% catalysts, inhibitors and pigments. Shade/color: C1. Instructions for use and SDS available at https://www.scottsdental.com/microhybrid-composite-syringe-scott-s-select.html.
SCOTT'S DENTAL SUPPLY L.L.C.
199-2007
In Commercial Distribution

  • D77819920070 ()

  • Weight: 4.5 Gram
199-2007

  • Dental composite resin

SCOTT'S SELECT MICROHYBRID SYRINGE 4.5 Gm (B3) - D77819920060

Scott’s Select Microhybrid Composite is indicated for direct aesthetic restoration of anterior and posterior teeth and can be used in limited occlusal function. Microhybrid Composite is a light activated, resin based dental restorative material. Microhybrid Composite consists of approximately 75wt% (54vol%) silanated 0.7 micron Barium glass and 0.01 micron silica, approximately 25wt$ Bis-GMA based dimethacrylate system, and approximately 1wt% catalysts, inhibitors and pigments. Shade/color: B3. Instructions for use and SDS available at https://www.scottsdental.com/microhybrid-composite-syringe-scott-s-select.html.
SCOTT'S DENTAL SUPPLY L.L.C.
199-2006
In Commercial Distribution

  • D77819920060 ()

  • Weight: 4.5 Gram
199-2006

  • Dental composite resin

SCOTT'S SELECT MICROHYBRID SYRINGE 4.5 Gm (B2) - D77819920050

Scott’s Select Microhybrid Composite is indicated for direct aesthetic restoration of anterior and posterior teeth and can be used in limited occlusal function. Microhybrid Composite is a light activated, resin based dental restorative material. Microhybrid Composite consists of approximately 75wt% (54vol%) silanated 0.7 micron Barium glass and 0.01 micron silica, approximately 25wt$ Bis-GMA based dimethacrylate system, and approximately 1wt% catalysts, inhibitors and pigments. Shade/color: B2. Instructions for use and SDS available at https://www.scottsdental.com/microhybrid-composite-syringe-scott-s-select.html.
SCOTT'S DENTAL SUPPLY L.L.C.
199-2005
In Commercial Distribution

  • D77819920050 ()

  • Weight: 4.5 Gram
199-2005

  • Dental composite resin

SCOTT'S SELECT MICROHYBRID SYRINGE 4.5 Gm (A3.5) - D77819920041

Scott’s Select Microhybrid Composite is indicated for direct aesthetic restoration of anterior and posterior teeth and can be used in limited occlusal function. Microhybrid Composite is a light activated, resin based dental restorative material. Microhybrid Composite consists of approximately 75wt% (54vol%) silanated 0.7 micron Barium glass and 0.01 micron silica, approximately 25wt$ Bis-GMA based dimethacrylate system, and approximately 1wt% catalysts, inhibitors and pigments. Shade/color: A3.5. Instructions for use and SDS available at https://www.scottsdental.com/microhybrid-composite-syringe-scott-s-select.html.
SCOTT'S DENTAL SUPPLY L.L.C.
199-2004
In Commercial Distribution

  • D77819920041 ()

  • Weight: 4.5 Gram
199-2004

  • Dental composite resin

SCOTT'S SELECT MICROHYBRID SYRINGE 4.5 Gm (A3) - D77819920030

Scott’s Select Microhybrid Composite is indicated for direct aesthetic restoration of anterior and posterior teeth and can be used in limited occlusal function. Microhybrid Composite is a light activated, resin based dental restorative material. Microhybrid Composite consists of approximately 75wt% (54vol%) silanated 0.7 micron Barium glass and 0.01 micron silica, approximately 25wt$ Bis-GMA based dimethacrylate system, and approximately 1wt% catalysts, inhibitors and pigments. Shade/color: A3. Instructions for use and SDS available at https://www.scottsdental.com/microhybrid-composite-syringe-scott-s-select.html.
SCOTT'S DENTAL SUPPLY L.L.C.
199-2003
In Commercial Distribution

  • D77819920030 ()

  • Weight: 4.5 Gram
199-2003

  • Dental composite resin

SCOTT'S SELECT MICROHYBRID SYRINGE 4.5 Gm (A2) - D77819920020

Scott’s Select Microhybrid Composite is indicated for direct aesthetic restoration of anterior and posterior teeth and can be used in limited occlusal function. Microhybrid Composite is a light activated, resin based dental restorative material. Microhybrid Composite consists of approximately 75wt% (54vol%) silanated 0.7 micron Barium glass and 0.01 micron silica, approximately 25wt$ Bis-GMA based dimethacrylate system, and approximately 1wt% catalysts, inhibitors and pigments. Shade/color: A2. Instructions for use and SDS available at https://www.scottsdental.com/microhybrid-composite-syringe-scott-s-select.html.
SCOTT'S DENTAL SUPPLY L.L.C.
199-2002
In Commercial Distribution

  • D77819920020 ()

  • Weight: 4.5 Gram
199-2002

  • Dental composite resin

SCOTT'S SELECT MICROHYBRID SYRINGE 4.5 Gm (A1) - D77819920010

Scott’s Select Microhybrid Composite is indicated for direct aesthetic restoration of anterior and posterior teeth and can be used in limited occlusal function. Microhybrid Composite is a light activated, resin based dental restorative material. Microhybrid Composite consists of approximately 75wt% (54vol%) silanated 0.7 micron Barium glass and 0.01 micron silica, approximately 25wt$ Bis-GMA based dimethacrylate system, and approximately 1wt% catalysts, inhibitors and pigments. Shade/color: A1. Instructions for use and SDS available at https://www.scottsdental.com/microhybrid-composite-syringe-scott-s-select.html.
SCOTT'S DENTAL SUPPLY L.L.C.
199-2001
In Commercial Distribution

  • D77819920010 ()

  • Weight: 4.5 Gram
199-2001

  • Dental composite resin

SCOTT'S SELECT PERMANENT RESIN CEMENT SYRINGE 7gm CLEAR - D77819910731

No Description
SCOTT'S DENTAL SUPPLY L.L.C.
199-1073
In Commercial Distribution

  • D77819910731 ()
199-1073

  • Dental composite resin

SCOTT'S SELECT PERMANENT RESIN CEMENT SYRINGE 7gm WHITE - D77819910701

No Description
SCOTT'S DENTAL SUPPLY L.L.C.
199-1070
In Commercial Distribution

  • D77819910701 ()
199-1070

  • Dental composite resin

SELECT TEMPORARY CEMENT TUBE PKG EUGENOL - D77819910630

No Description
SCOTT'S DENTAL SUPPLY L.L.C.
199-1063
Not in Commercial Distribution

  • D77819910630 ()
199-1063

  • Zinc phosphate dental cement

Pro-V C&B A3 50ml Syr. Refill Pkg - D757H403A3P1

No Description
BISCO INC.
H-403A3P
Not in Commercial Distribution

  • D757H403A3P1 ()
H-403A3P

  • Preformed dental crown, temporary

Ipana 5% Sodium Fluoride Varnish - Melon - 00060705405333

No Description
MAXILL, INC.
40533
In Commercial Distribution

  • 00060705405333 ()
  • 90060705405336 ()


  • Dental cavity varnish

Ipana 5% Sodium Fluoride Varnish - Bubble Gum - 00060705405326

No Description
MAXILL, INC.
40532
In Commercial Distribution

  • 00060705405326 ()
  • 90060705405329 ()


  • Dental cavity varnish

Ipana 5% Sodium Fluoride Varnish - Wintergreen - 00060705405319

No Description
MAXILL, INC.
40531
In Commercial Distribution

  • 00060705405319 ()
  • 90060705405312 ()


  • Dental cavity varnish

Ipana 5% Sodium Fluoride Varnish - Caramel - 00060705405302

No Description
MAXILL, INC.
40530
In Commercial Distribution

  • 00060705405302 ()
  • 90060705405305 ()


  • Dental cavity varnish

Memory Staple - B56217624WB0

Memory Staple 30 x 30-2 x 3mm / LRG
Wishbone Medical, Inc.
17624WB
Not in Commercial Distribution

  • B56217624WB0 ()


  • Orthopaedic bone staple, non-adjustable

Onyx HD 500 - 00836462005129

105-8101-500 ONYX HD500 KIT ANEURYS
Micro Therapeutics, Inc.
105-8101-500
In Commercial Distribution

  • 00836462005129 ()


  • Neurovascular embolization plug

ROM Plus® Strip Quality Control - 00814247020468

ROM Plus®, Easy Strip Quality Control for Fetal Membranes Rupture Test
CLINICAL INNOVATIONS, LLC
ROM-QCS
In Commercial Distribution

  • 20814247020462 ()
  • 10814247020465 ()
  • 00814247020468 ()


  • Amniotic fluid leak detection device IVD

ROM Plus® Quality Control Kit - 00814247020451

ROM Plus®, Quality Control for Fetal Membranes Rupture Test
CLINICAL INNOVATIONS, LLC
ROM-QC
In Commercial Distribution

  • 20814247020455 ()
  • 10814247020458 ()
  • 00814247020451 ()


  • Amniotic fluid leak detection device IVD

ROM Plus®, Fetal Membranes Rupture Collection Kit - 00814247020444

ROM Plus® Complete Kit Fetal Membranes Rupture Test
CLINICAL INNOVATIONS, LLC
ROM-6000
In Commercial Distribution

  • 20814247020448 ()
  • 10814247020441 ()
  • 00814247020444 ()


  • Amniotic fluid leak detection device IVD

ROM Plus®, Fetal Membranes Rupture Test - 00814247020437

ROM Plus® Complete Kit Fetal Membranes Rupture Test
CLINICAL INNOVATIONS, LLC
ROM-5025
In Commercial Distribution

  • 10814247020434 ()
  • 00814247020437 ()


  • Amniotic fluid leak detection device IVD

ROM Plus®, Fetal Membranes Rupture Test - 00814247020420

ROM Plus® Complete Test Kit
CLINICAL INNOVATIONS, LLC
ROM-5000
In Commercial Distribution

  • 20814247020424 ()
  • 10814247020427 ()
  • 00814247020420 ()


  • Amniotic fluid leak detection device IVD

ROM Plus®, Fetal Membranes Rupture Test - 00814247020406

ROM Plus® Easy Strip Complete Kit Fetal Membranes Rupture Test
CLINICAL INNOVATIONS, LLC
ROM-1025
In Commercial Distribution

  • 00814247020406 ()
  • 10814247020403 ()
  • 20814247020400 ()


  • Amniotic fluid leak detection device IVD

RVG 6100 - 60192155314162

RVG 6100 - SIZE 0 w/o USB HUB
CARESTREAM DENTAL LLC
RVG 6100
In Commercial Distribution

  • 60192155314162 ()
5314166

  • Dental digital imaging sensor, intraoral

RVG 6200 - 60192155313981

RVG 6200 #1 FOR USE W. RVG CONNECT
CARESTREAM DENTAL LLC
RVG 6200
In Commercial Distribution

  • 60192155313981 ()
5313986

  • Dental digital imaging sensor, intraoral

RVG 5200 - 60192155311307

RVG 5200 SIZE 2
CARESTREAM DENTAL LLC
RVG 5200
In Commercial Distribution

  • 60192155311307 ()
5311303

  • Dental digital imaging sensor, intraoral

RVG 5200 - 60192155311291

RVG 5200 SIZE 1
CARESTREAM DENTAL LLC
RVG 5200
In Commercial Distribution

  • 60192155311291 ()
5311295

  • Dental digital imaging sensor, intraoral

CS 7600 SLOT PANEL - 60889971023711

CS 7600 SLOT PANEL SIZE 4
CARESTREAM HEALTH, INC.
CS 7600 SLOT PANEL
In Commercial Distribution

  • 60889971023711 ()
1023712

  • Dental computed radiography digital imaging scanner

CS 7600 SLOT PANEL - 60889971023704

CS 7600 SLOT PANEL SIZE 1-3
CARESTREAM HEALTH, INC.
CS 7600 SLOT PANEL
In Commercial Distribution

  • 60889971023704 ()
1023704

  • Dental computed radiography digital imaging scanner

EV Screens - 60889971015556

EV SCR, 20PR 15x30cm-Panoramic
CARESTREAM HEALTH, INC.
EV Screens
In Commercial Distribution

  • 60889971015556 ()
1015551

  • X-ray intensifying screen

Extraoral Cassette with LANEX Regular Screens - 60889971002815

Extraoral Cass w/ LANEX REG SCR 18x24cm
CARESTREAM HEALTH, INC.
Extraoral Cassette with LANEX Regular Screens
Not in Commercial Distribution

  • 60889971002815 ()
1002815

  • X-ray film cassette, automatic film changing
  • X-ray intensifying screen

Extraoral Cassette with LANEX Regular Screens - 60889971002808

Extraoral Cass w/ LANEX REG SCR 8x10in
CARESTREAM HEALTH, INC.
Extraoral Cassette with LANEX Regular Screens
In Commercial Distribution

  • 60889971002808 ()
1002807

  • X-ray intensifying screen
  • X-ray film cassette, automatic film changing

Extraoral Cassette with EV Screens - 60889971002785

Extraoral Cass w/ EV SCR 8x10in
CARESTREAM HEALTH, INC.
Extraoral Cassette with EV Screens
In Commercial Distribution

  • 60889971002785 ()
1002781

  • X-ray film cassette, automatic film changing
  • X-ray intensifying screen

Extraoral Cassette with LANEX Regular Screens - 60889971002778

Extraoral Cass w/ LANEX REG SCR 15x30cm
CARESTREAM HEALTH, INC.
Extraoral Cassette with LANEX Regular Screens
In Commercial Distribution

  • 60889971002778 ()
1002773

  • X-ray intensifying screen
  • X-ray film cassette, automatic film changing

Extraoral Cassette with LANEX Medium Screens - 60889971002747

Extraoral Cass w/ LANEX MED SCR 15x30cm
CARESTREAM HEALTH, INC.
Extraoral Cassette with LANEX Medium Screens
In Commercial Distribution

  • 60889971002747 ()
1002740

  • X-ray intensifying screen
  • X-ray film cassette, automatic film changing

Extraoral Cassette with EV Screens - 60889971002730

Extraoral Cass w/ EV SCR 15x30cm
CARESTREAM HEALTH, INC.
Extraoral Cassette with EV Screens
In Commercial Distribution

  • 60889971002730 ()
1002732

  • X-ray intensifying screen
  • X-ray film cassette, automatic film changing

DISPETTE® - 07612964013304

DISPETTE 2 SALINE
Guest Scientific AG
FH1600
Not in Commercial Distribution

  • 07612964013311 ()
  • 07612964013304 ()
  • 07612964013342 ()
FH1600

  • Erythrocyte sedimentation rate (ESR) IVD, kit

DISPETTE® - 07612964000762

DISPETTE 2 CITRATE
Guest Scientific AG
FH1650
Not in Commercial Distribution

  • 07612964000809 ()
  • 07612964000762 ()
  • 07612964000786 ()
FH1650

  • Erythrocyte sedimentation rate (ESR) IVD, kit

CR Cassettes for Vita Systems - 60889978964390

CARESTREAM CR Cassette 25x30/10x12
CARESTREAM HEALTH, INC.
CR Cassettes for Vita Systems
In Commercial Distribution

  • 60889978964390 ()
8964397

  • Digital imaging cassette/phosphor plate

DIRECTVIEW CR Cassette with PQ Screen - 60889978933884

SGL 35X35CM DIRECTVIEW PQ SCR
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Cassette with PQ Screen
In Commercial Distribution

  • 60889978933884 ()
8933889

  • Digital imaging cassette/phosphor plate

DIRECTVIEW CR Mammography Cassette with EHR-M3 Screen - 60889978869848

24X30CM CR MAMMO SCR EHR-M3
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Mammography Cassette with EHR-M3 Screen
In Commercial Distribution

  • 60889978869848 ()
8869844

  • Digital imaging cassette/storage phosphor screen, mammographic

DIRECTVIEW CR Cassette with PQ Screen - 60889978824601

35x43CM DV CR REPLACMT PLATE/PQ SCR
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Cassette with PQ Screen
In Commercial Distribution

  • 60889978824601 ()
8824609

  • Digital imaging cassette/phosphor plate

LANEX Regular Screens - 60889978802098

LANEX Regular SCR 20PR 4.88x14.75in H-G
CARESTREAM HEALTH, INC.
LANEX Regular Screens
In Commercial Distribution

  • 60889978802098 ()
  • 00889978802096 ()
8802092

  • X-ray intensifying screen

EV Screens - 60889978793457

EV SCR 1PR 15x30cm NF
CARESTREAM HEALTH, INC.
EV Screens
In Commercial Distribution

  • 60889978793457 ()
8793457

  • X-ray intensifying screen

Imaging Plate - 60889978770717

CR IMAGING PLATE PAN V2 5X12IN
CARESTREAM HEALTH, INC.
Imaging Plate
In Commercial Distribution

  • 60889978770717 ()
8770711

  • Digital imaging storage phosphor screen
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