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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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SEPTODONT ETCHANT 60GM SYR KIT
SEPTODONT, INC
01C2035
In Commercial Distribution

  • 00303620000642 ()

  • Weight: 60 Gram
01C2035

  • Dental etching solution
SEPTODONT USA SEPTOETCH 12-1.6GM SYR
SEPTODONT, INC
01C2034
In Commercial Distribution

  • 00303620000635 ()

  • Weight: 1.5 Gram
01C2034

  • Dental etching solution
SEPTODONT ETCH 4 X 4GM KIT
SEPTODONT, INC
01C2032
In Commercial Distribution

  • 00303620000628 ()

  • Weight: 4 Gram
01C2032

  • Dental etching solution
No Description
SEPTODONT, INC
01C2008
In Commercial Distribution

  • 00303620000550 ()

  • Weight: 4 Gram


  • Dental composite resin
No Description
SEPTODONT, INC
01C2006
In Commercial Distribution

  • 00303620000543 ()

  • Weight: 4 Gram
01C2006

  • Dental composite resin
No Description
SEPTODONT, INC
01C2004
In Commercial Distribution

  • 00303620000536 ()

  • Weight: 4 Gram
01C2004

  • Dental composite resin
SEPTODONT ADHERENCE SC 2-9GM DBL BAR SYR
SEPTODONT, INC
01C2003
In Commercial Distribution

  • 00303620000529 ()

  • Weight: 9 Gram
01C2003

  • Dental composite resin
SEPTODONT ADHERENCE REF SYR CLEAR 4G
SEPTODONT, INC
01C2002
In Commercial Distribution

  • 00303620000512 ()

  • Weight: 4 Gram
01C2002

  • Dental composite resin
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 for Fetal Membranes Rupture Test
CLINICAL INNOVATIONS, LLC
ROM-QC
In Commercial Distribution

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


  • Amniotic fluid leak detection device IVD
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® Complete Kit Fetal Membranes Rupture Test
CLINICAL INNOVATIONS, LLC
ROM-5025
In Commercial Distribution

  • 10814247020434 ()
  • 00814247020437 ()


  • Amniotic fluid leak detection device IVD
ROM Plus® Complete Test Kit
CLINICAL INNOVATIONS, LLC
ROM-5000
In Commercial Distribution

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


  • Amniotic fluid leak detection device IVD
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
No Description
BISCO INC.
H-403A3P
Not in Commercial Distribution

  • D757H403A3P1 ()
H-403A3P

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

  • B56217624WB0 ()


  • Orthopaedic bone staple, non-adjustable
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 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 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 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 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 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 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
No Description
SCOTT'S DENTAL SUPPLY L.L.C.
199-1073
In Commercial Distribution

  • D77819910731 ()
199-1073

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

  • D77819910701 ()
199-1070

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

  • D77819910630 ()
199-1063

  • Zinc phosphate dental cement
Scott's Select Flowable Composite is a 41% filled (by volume) composite based on a resin system of BIS-GMA and triethylene glycol dimetacrylate. The filler has particle sizes ranging from sub-micron to 8 microns. Contains 2% Sodium Fluoride (by weight). There is about 1wt% catalysts, inhibitors and pigments. Shade/Color: D3. Instructions for use and SDS available at: https://www.scottsdental.com/flowable-composite-scott-s-select.html
SCOTT'S DENTAL SUPPLY L.L.C.
199-5016
In Commercial Distribution

  • D77819950161 ()
  • D77819950160 ()

  • Weight: 2 Gram
199-5016

  • Dental composite resin
Scott's Select Flowable Composite is a 41% filled (by volume) composite based on a resin system of BIS-GMA and triethylene glycol dimetacrylate. The filler has particle sizes ranging from sub-micron to 8 microns. Contains 2% Sodium Fluoride (by weight). There is about 1wt% catalysts, inhibitors and pigments. Shade/Color: C4. Instructions for use and SDS available at: https://www.scottsdental.com/flowable-composite-scott-s-select.html
SCOTT'S DENTAL SUPPLY L.L.C.
199-5014
In Commercial Distribution

  • D77819950141 ()
  • D77819950140 ()

  • Weight: 2 Gram
199-5014

  • Dental composite resin
Scott's Select Flowable Composite is a 41% filled (by volume) composite based on a resin system of BIS-GMA and triethylene glycol dimetacrylate. The filler has particle sizes ranging from sub-micron to 8 microns. Contains 2% Sodium Fluoride (by weight). There is about 1wt% catalysts, inhibitors and pigments. Shade/Color: C2. Instructions for use and SDS available at: https://www.scottsdental.com/flowable-composite-scott-s-select.html
SCOTT'S DENTAL SUPPLY L.L.C.
199-5013
In Commercial Distribution

  • D77819950131 ()
  • D77819950130 ()

  • Weight: 2 Gram
199-5013

  • Dental composite resin
Scott's Select Flowable Composite is a 41% filled (by volume) composite based on a resin system of BIS-GMA and triethylene glycol dimetacrylate. The filler has particle sizes ranging from sub-micron to 8 microns. Contains 2% Sodium Fluoride (by weight). There is about 1wt% catalysts, inhibitors and pigments. Shade/Color: B1. Instructions for use and SDS available at: https://www.scottsdental.com/flowable-composite-scott-s-select.html
SCOTT'S DENTAL SUPPLY L.L.C.
199-5011
In Commercial Distribution

  • D77819950111 ()
  • D77819950110 ()

  • Weight: 2 Gram
199-5011

  • Dental composite resin
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