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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 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 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 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 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
No Description
SEPTODONT, INC
01E0130
In Commercial Distribution

  • 10303620001417 ()

  • Weight: 7.5 Gram


  • Orthodontic bracket adhesive
DIRECTVIEW CR Cassett with PQ Scrn 15x30
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Gridded Cassette with PQ Screen
In Commercial Distribution

  • 60889978909889 ()
  • 40889978909885 ()
8909889

  • Digital imaging cassette/phosphor plate
DIRECTVIEW CR Cassett with PQ Scrn 24x30
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Gridded Cassette with PQ Screen
In Commercial Distribution

  • 60889978864812 ()
  • 40889978864818 ()
8864811

  • Digital imaging cassette/phosphor plate
DIRECTVW CR Mammo Cass EHR-M Scrn 24x30
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Mammography Cassette with EHR-M Screen
Not in Commercial Distribution

  • 60889978792122 ()
  • 40889978792128 ()
8792129

  • Digital imaging cassette/storage phosphor screen, mammographic
18X24CM DVIEW CR MAMMO SCR EHR-M
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Mammography Cassette with EHR-M Screen
In Commercial Distribution

  • 60889978188345 ()
  • 40889978188341 ()
8188344

  • Digital imaging cassette/storage phosphor screen, mammographic
DIRECTVW CR Mammo Cass EHR-M3 Scrn 24x30
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Mammography Cassette with EHR-M3 Screen
In Commercial Distribution

  • 60889978156184 ()
  • 40889978156180 ()
8156184

  • Digital imaging cassette/storage phosphor screen, mammographic
FLEXIBLE PHOSPHOR SCREEN GP-2 24X30 CM
CARESTREAM HEALTH, INC.
Flexible Phosphor Screen GP-2
In Commercial Distribution

  • 60889978145423 ()
  • 40889978145429 ()
8145427

  • Digital imaging storage phosphor screen
CR SEMI-FIN PLATE PAN 5X12IN
CARESTREAM HEALTH, INC.
CS 7400
In Commercial Distribution

  • 60889978666942 ()
  • 40889978666948 ()
8666943

  • Dental computed radiography digital imaging scanner
DIRECTVIEW CR Cassett with PQ Scrn 35x35
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Gridded Cassette with PQ Screen
In Commercial Distribution

  • 60889978645442 ()
  • 40889978645448 ()
8645442

  • Digital imaging cassette/phosphor plate
DIRECTVIEW CR Grid Cass w PQ Scrn 35x43
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Gridded Cassette with PQ Screen
Not in Commercial Distribution

  • 60889978637683 ()
  • 40889978637689 ()
8637688

  • Digital imaging cassette/phosphor plate
(2) SZ 3 DENTAL CR I/O IMAG PLATES
CARESTREAM HEALTH, INC.
Imaging Plate
In Commercial Distribution

  • 60889978610099 ()
  • 40889978610095 ()
  • 00889978610097 ()
8610099

  • Digital imaging storage phosphor screen
MXB FILM 8X10IN 100SH
CARESTREAM HEALTH, INC.
Medical X-ray Blue / MXB Film
In Commercial Distribution

  • 60889978609895 ()
  • 40889978609891 ()
  • 00889978609893 ()
8609893

  • Medical x-ray film, screen
MXB FILM 10X12IN 100SH
CARESTREAM HEALTH, INC.
Medical X-ray Blue / MXB Film
In Commercial Distribution

  • 60889978609871 ()
  • 40889978609877 ()
  • 00889978609879 ()
8609877

  • Medical x-ray film, screen
MXB FILM 11X14IN 100SH
CARESTREAM HEALTH, INC.
Medical X-ray Blue / MXB Film
In Commercial Distribution

  • 60889978609864 ()
  • 40889978609860 ()
  • 00889978609862 ()
8609869

  • Medical x-ray film, screen
MXB FILM 35X35-14X14 100SH
CARESTREAM HEALTH, INC.
Medical X-ray Blue / MXB Film
In Commercial Distribution

  • 60889978609833 ()
  • 40889978609839 ()
  • 00889978609831 ()
8609836

  • Medical x-ray film, screen
MXB FILM 35X43-14X17 100SH
CARESTREAM HEALTH, INC.
Medical X-ray Blue / MXB Film
In Commercial Distribution

  • 60889978609819 ()
  • 40889978609815 ()
  • 00889978609817 ()
8609810

  • Medical x-ray film, screen
CR SEMI-FIN PLATE PAN 15X30CM
CARESTREAM HEALTH, INC.
CS 7400
In Commercial Distribution

  • 60889978427963 ()
  • 40889978427969 ()
8427965

  • Dental computed radiography digital imaging scanner
DIRECTVIEW CR Cassett with PQ Scrn 35x43
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Cassette with PQ Screen
In Commercial Distribution

  • 60889978413515 ()
  • 40889978413511 ()
8413510

  • Digital imaging cassette/phosphor plate
(2) SZ 1 DENTAL CR I/O IMAG PLATES
CARESTREAM HEALTH, INC.
Imaging Plate
In Commercial Distribution

  • 60889978406845 ()
  • 40889978406841 ()
  • 00889978406843 ()
8406845

  • Digital imaging storage phosphor screen
18X24CM CR MAMMO SCR EHR-M3
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Mammography Cassette with EHR-M3 Screen
In Commercial Distribution

  • 60889978336197 ()
  • 40889978336193 ()
8336190

  • Digital imaging cassette/storage phosphor screen, mammographic
Flexible Phosphor Scrn GP-2 25x30/10x12
CARESTREAM HEALTH, INC.
Flexible Phosphor Screen GP-2
In Commercial Distribution

  • 60889978271061 ()
  • 40889978271067 ()
8271066

  • Digital imaging storage phosphor screen
CR SEMI-FIN PLATE PAN V2 5X12IN
CARESTREAM HEALTH, INC.
CS 7400
In Commercial Distribution

  • 60889978214235 ()
  • 40889978214231 ()
8214231

  • Dental computed radiography digital imaging scanner
LANEX Regular SCR 1PR 13x18cm
CARESTREAM HEALTH, INC.
LANEX Regular Screens
In Commercial Distribution

  • 60889971976208 ()
  • 40889971976204 ()
1976208

  • X-ray intensifying screen
18X24 CR MAMMO CASS W/SNP-M1 SCREEN
CARESTREAM HEALTH, INC.
CARESTREAM CR Mammography Cassette with SNP-M1 Screen
In Commercial Distribution

  • 60889971941503 ()
  • 40889971941509 ()
1941509

  • Digital imaging cassette/storage phosphor screen, mammographic
DIRECTVW CR Mammo Cass EHR-M3 Scrn 18X24
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Mammography Cassette with EHR-M3 Screen
In Commercial Distribution

  • 60889971790316 ()
  • 40889971790312 ()
1790310

  • Digital imaging cassette/storage phosphor screen, mammographic
(2) SZ 4 DENTAL CR I/O IMAG PLATES
CARESTREAM HEALTH, INC.
Imaging Plate
In Commercial Distribution

  • 60889971683373 ()
  • 40889971683379 ()
  • 00889971683371 ()
1683374

  • Digital imaging storage phosphor screen
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