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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 (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 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 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

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

Acu-Flow™ Rigid Tray Cartridge - 00359883003388

Hydrophillic Impression Material
DEN-MAT HOLDINGS, LLC
1-016409
In Commercial Distribution

  • 00359883003388 ()

  • Total Volume: 50 Milliliter
1-016409

  • Silicone dental impression material

Acu-Flow™ Medium Body Cartridge - 00359883003371

Hydrophillic Impression Material
DEN-MAT HOLDINGS, LLC
1-016408
In Commercial Distribution

  • 00359883003371 ()

  • Total Volume: 50 Milliliter
1-016408

  • Silicone dental impression material

Acu-Flow™ Heavy Body Cartridge - 00359883003364

Hydrophillic Impression Material
DEN-MAT HOLDINGS, LLC
1-016407
In Commercial Distribution

  • 00359883003364 ()

  • Total Volume: 50 Milliliter
1-016407

  • Silicone dental impression material

Acu-Flow™ Light Body Plus Cartridge - 00359883003357

Hydrophillic Impression Material
DEN-MAT HOLDINGS, LLC
1-016406
In Commercial Distribution

  • 00359883003357 ()

  • Total Volume: 50 Milliliter
1-016406

  • Silicone dental impression material

Acu-Flow™ Putty Kit - 00359883003340

Hydrophillic Impression Material
DEN-MAT HOLDINGS, LLC
1-016405
In Commercial Distribution

  • 00359883003340 ()

  • Total Volume: 600 Milliliter
1-016405

  • Silicone dental impression material

Acu-Flow™ Monophase 6-Pack - 00359883003333

Hydrophillic Impression Material
DEN-MAT HOLDINGS, LLC
1-016404
In Commercial Distribution

  • 00359883003326 ()
  • 00359883003333 ()

  • Total Volume: 300 Milliliter
1-016404

  • Silicone dental impression material

Acu-Flow™ Rigid Tray 6-Pack - 00359883003319

Hydrophillic Impression Material
DEN-MAT HOLDINGS, LLC
1-016403
In Commercial Distribution

  • 00359883003302 ()
  • 00359883003319 ()

  • Total Volume: 300 Milliliter
1-016403

  • Silicone dental impression material

Acu-Flow™ Heavy Body 6-Pack - 00359883003296

Hydrophillic Impression Material
DEN-MAT HOLDINGS, LLC
1-016402
In Commercial Distribution

  • 00359883003289 ()
  • 00359883003296 ()

  • Total Volume: 300 Milliliter
1-016402

  • Silicone dental impression material

Acu-Flow™ Light Body 6-Pack - 00359883003272

Hydrophillic Impression Material
DEN-MAT HOLDINGS, LLC
1-016401
In Commercial Distribution

  • 00359883003265 ()
  • 00359883003272 ()

  • Total Volume: 300 Milliliter
1-016401

  • Silicone dental impression material

Acu-Flow™ Bite Registration 6-Pack - 00359883003258

Hydrophillic Impression Material
DEN-MAT HOLDINGS, LLC
1-016400
In Commercial Distribution

  • 00359883003241 ()
  • 00359883003258 ()

  • Total Volume: 300 Milliliter
1-016400

  • Silicone dental impression material

Acu-Flow™ Best-Bite Bite Registration - 00359883003227

Hydrophillic Impression Material
DEN-MAT HOLDINGS, LLC
1-016397
In Commercial Distribution

  • 00359883003227 ()

  • Total Volume: 50 Milliliter
1-016397

  • Silicone dental impression material

Affinity™ Heavy Body FS 120ml 2-Pack - 00359883002114

VPS Impression Material
DEN-MAT HOLDINGS, LLC
023406
In Commercial Distribution

  • 00359883002107 ()
  • 00359883002114 ()

  • Total Volume: 120 Milliliter
023406

  • Silicone dental impression material

Affinity™ Heavy Body RS 120ml 2-Pack - 00359883002053

VPS Impression Material
DEN-MAT HOLDINGS, LLC
023401
In Commercial Distribution

  • 00359883002046 ()
  • 00359883002053 ()

  • Total Volume: 120 Milliliter
023401

  • Silicone dental impression material

Affinity™ Inflex FS 120ml 2-Pack - 00359883001995

VPS Impression Material
DEN-MAT HOLDINGS, LLC
022406
In Commercial Distribution

  • 00359883001988 ()
  • 00359883001995 ()

  • Total Volume: 120 Milliliter
022406

  • Silicone dental impression material

Affinity™ Inflex RS 120ml 2-Pack - 00359883001933

VPS Impression Material
DEN-MAT HOLDINGS, LLC
022401
In Commercial Distribution

  • 00359883001926 ()
  • 00359883001933 ()

  • Total Volume: 120 Milliliter
022401

  • Silicone dental impression material

Affinity™ Heavy Body FS 120ml Cartridge - 00359883001599

VPS Impression Material
DEN-MAT HOLDINGS, LLC
013406
In Commercial Distribution

  • 00359883001599 ()

  • Total Volume: 120 Milliliter
013406

  • Silicone dental impression material

Affinity™ Heavy Body RS 120ml Cartridge - 00359883001575

VPS Impression Material
DEN-MAT HOLDINGS, LLC
013401
In Commercial Distribution

  • 00359883001575 ()

  • Total Volume: 120 Milliliter
013401

  • Silicone dental impression material

Affinity™ Inflex FS 120ml Cartridge - 00359883001513

VPS Impression Material
DEN-MAT HOLDINGS, LLC
012406
In Commercial Distribution

  • 00359883001513 ()

  • Total Volume: 120 Milliliter
012406

  • Silicone dental impression material

Affinity™ Inflex RS 120ml Cartridge - 00359883001490

VPS Impression Material
DEN-MAT HOLDINGS, LLC
012401
In Commercial Distribution

  • 00359883001490 ()

  • Total Volume: 120 Milliliter
012401

  • Silicone dental impression material

Acu-Flow™ Bite Registration Cartridge - 00359883006631

Hydrophillic Impression Material
DEN-MAT HOLDINGS, LLC
1-016399
In Commercial Distribution

  • 00359883006631 ()

  • Total Volume: 50 Milliliter
1-016399

  • Silicone dental impression material

Tissue Goo™ Hemostatic Gel 4-Pack - 00359883005665

Gingival Retraction Solution
DEN-MAT HOLDINGS, LLC
641904
In Commercial Distribution

  • 00359883005665 ()

  • Total Volume: 12 Milliliter
641904

  • Gingival retraction solution
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