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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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Nanohybrid Composite contains a new ytterbium fluoride mono-dispersed nano-sized particle which combined with regular silica and barium glass composes a state of the art nano-filler system. Nanohybrid Composite is a high viscosity composite that will resist sticking to instruments, yet will have sufficient flow to adapt to the walls of the cavity preparation. Nanohybrid Composite is radio-opaque and provides high compressive and flexural strengths along with a low water uptake. Nanohybrid Composite meets the ISO 4049 standard (Type 1, Class 2). Color/Shade: B2 SDS and Instructions for use available at: https://www.scottsdental.com/nanohybrid-composite-syringe-scott-s-select.html
SCOTT'S DENTAL SUPPLY L.L.C.
199-3005
In Commercial Distribution

  • D77819930050 ()

  • Weight: 4.5 Gram
199-3005

  • Dental composite resin
Nanohybrid Composite contains a new ytterbium fluoride mono-dispersed nano-sized particle which combined with regular silica and barium glass composes a state of the art nano-filler system. Nanohybrid Composite is a high viscosity composite that will resist sticking to instruments, yet will have sufficient flow to adapt to the walls of the cavity preparation. Nanohybrid Composite is radio-opaque and provides high compressive and flexural strengths along with a low water uptake. Nanohybrid Composite meets the ISO 4049 standard (Type 1, Class 2). Color/Shade: A3.5 SDS and Instructions for use available at: https://www.scottsdental.com/nanohybrid-composite-syringe-scott-s-select.html
SCOTT'S DENTAL SUPPLY L.L.C.
199-3004
In Commercial Distribution

  • D77819930040 ()

  • Weight: 4.5 Gram
199-3004

  • Dental composite resin
Nanohybrid Composite contains a new ytterbium fluoride mono-dispersed nano-sized particle which combined with regular silica and barium glass composes a state of the art nano-filler system. Nanohybrid Composite is a high viscosity composite that will resist sticking to instruments, yet will have sufficient flow to adapt to the walls of the cavity preparation. Nanohybrid Composite is radio-opaque and provides high compressive and flexural strengths along with a low water uptake. Nanohybrid Composite meets the ISO 4049 standard (Type 1, Class 2). Color/Shade: A3 SDS and Instructions for use available at: https://www.scottsdental.com/nanohybrid-composite-syringe-scott-s-select.html
SCOTT'S DENTAL SUPPLY L.L.C.
199-3003
In Commercial Distribution

  • D77819930030 ()

  • Weight: 4.5 Gram
199-3003

  • Dental composite resin
Nanohybrid Composite contains a new ytterbium fluoride mono-dispersed nano-sized particle which combined with regular silica and barium glass composes a state of the art nano-filler system. Nanohybrid Composite is a high viscosity composite that will resist sticking to instruments, yet will have sufficient flow to adapt to the walls of the cavity preparation. Nanohybrid Composite is radio-opaque and provides high compressive and flexural strengths along with a low water uptake. Nanohybrid Composite meets the ISO 4049 standard (Type 1, Class 2). Color/Shade: A2 SDS and Instructions for use available at: https://www.scottsdental.com/nanohybrid-composite-syringe-scott-s-select.html
SCOTT'S DENTAL SUPPLY L.L.C.
199-3002
In Commercial Distribution

  • D77819930020 ()

  • Weight: 4.5 Gram
199-3002

  • Dental composite resin
Nanohybrid Composite contains a new ytterbium fluoride mono-dispersed nano-sized particle which combined with regular silica and barium glass composes a state of the art nano-filler system. Nanohybrid Composite is a high viscosity composite that will resist sticking to instruments, yet will have sufficient flow to adapt to the walls of the cavity preparation. Nanohybrid Composite is radio-opaque and provides high compressive and flexural strengths along with a low water uptake. Nanohybrid Composite meets the ISO 4049 standard (Type 1, Class 2). Color/Shade: A1 SDS and Instructions for use available at: https://www.scottsdental.com/nanohybrid-composite-syringe-scott-s-select.html
SCOTT'S DENTAL SUPPLY L.L.C.
199-3001
In Commercial Distribution

  • D77819930010 ()

  • Weight: 4.5 Gram
199-3001

  • 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: C2. 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.
199-2014
In Commercial Distribution

  • D77819920140 ()
199-2014

  • 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: 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 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
Fluoroseal is a Light-Cured Cavity Liner used for Building the Cavity Floor in Deep Restorations. Also Provide Protection Against Irritants from Restoratives or Auxiliary Materials. Dentin Shade Syringe. Ziploc Bag. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 75-035 IZ
In Commercial Distribution

  • D801ID75035IZ1 ()
75-035

  • Dental cavity varnish
SciPharm CuRay Match Metal Primer for Veneers or Cast Restorations (Primet). Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 7010 I
In Commercial Distribution

  • D801ID7010I1 ()
70-10

  • Dental composite resin
CuRay Eclipse Visible Light-Cured Orthodontic Adhesive Kit. Italian
SCIENTIFIC PHARMACEUTICALS, INC.
ID 60-05 I
In Commercial Distribution

  • D801ID6005I1 ()
60-05

  • Dentine adhesive
CuRay Eclipse Visible Light-Cured Orthodontic Adhesive Enamel Primer Bottle. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 60-052 I
In Commercial Distribution

  • D801ID60052I1 ()
60-052

  • Dentine adhesive
CuRay Eclipse Visible Light-Cured Orthodontic Adhesive Syringe. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 60-051 I
In Commercial Distribution

  • D801ID60051I1 ()
60-05

  • Dentine adhesive
CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade Universal Opaque Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-224 I
In Commercial Distribution

  • D801ID50224I1 ()
50-224

  • Dental composite resin
CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade Incisal Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-222 I
In Commercial Distribution

  • D801ID50222I1 ()
50-222

  • Dental composite resin
CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade A4 Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-219 I
In Commercial Distribution

  • D801ID50219I1 ()
50-219

  • Dental composite resin
CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade C4 Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-218 I
In Commercial Distribution

  • D801ID50218I1 ()
50-218

  • Dental composite resin
CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade B2 Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-217 I
In Commercial Distribution

  • D801ID50217I1 ()
50-217

  • Dental composite resin
CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade C2 Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-216 I
In Commercial Distribution

  • D801ID50216I1 ()
50-216

  • Dental composite resin
CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade C3/D3Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-215 I
In Commercial Distribution

  • D801ID50215I1 ()
50-215

  • Dental composite resin
Visible Light-Cured Restorative, Resin Based. Universal Bonding Agent. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-121 I
In Commercial Distribution

  • D801ID50121I1 ()
50-121

  • Dental composite resin
CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade B3 Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-214 I
In Commercial Distribution

  • D801ID50214I1 ()
50-214

  • Dental composite resin
CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade A1/B1 Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-213 I
In Commercial Distribution

  • D801ID50213I1 ()
50-213

  • Dental composite resin
CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade A3.5 Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-212 I
In Commercial Distribution

  • D801ID50212I1 ()
50-212

  • Dental composite resin
CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade A2 Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-211
In Commercial Distribution

  • D801ID50211I1 ()
50-211

  • Dental composite resin
CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade A3 Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-210
In Commercial Distribution

  • D801ID50210I1 ()
50-210

  • Dental composite resin
Cross-linking agent containing silan agent to improve adhesion
ITENA CLINICAL
SILAN-IT
In Commercial Distribution

  • 03760260223119 ()


  • Dental prosthesis priming agent
DISPETTE 2 SALINE
Guest Scientific AG
FH1600
Not in Commercial Distribution

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

  • Erythrocyte sedimentation rate (ESR) IVD, kit
DISPETTE 2 CITRATE
Guest Scientific AG
FH1650
Not in Commercial Distribution

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

  • Erythrocyte sedimentation rate (ESR) IVD, kit
The Aqueduct SED Cartridge is part of the Aqueduct SED System. This disposable tubing set interfaces with the Aqueduct SED Console (ACCCON200) for monitoring of intracranial pressure (ICP) and draining and monitoring of CSF flow from the lateral ventricles.
AQUEDUCT CRITICAL CARE, INC.
ACC-CART-101V
In Commercial Distribution

  • ACCCARTV101 ()


  • Cerebrospinal fluid pressure regulation system sensor/tubing set
The Aqueduct SED Cartridge is part of the Aqueduct SED System. This disposable tubing set interfaces with the Aqueduct SED Console (ACCCON200) for draining and monitoring of CSF flow from the lumbar region.
AQUEDUCT CRITICAL CARE, INC.
ACC-CART-200L
In Commercial Distribution

  • ACCCARTL200 ()


  • Cerebrospinal fluid pressure regulation system sensor/tubing set
The Aqueduct SED Cartridge is part of the Aqueduct SED System. This disposable tubing set interfaces with the Aqueduct SED Console for monitoring of intracranial pressure (ICP) and draining and monitoring of CSF flow from the lateral ventricles.
AQUEDUCT CRITICAL CARE, INC.
ACC-CART-101
In Commercial Distribution

  • ACCCART101 ()


  • Cerebrospinal fluid pressure regulation system sensor/tubing set
The Aqueduct SED Cartridge is part of the Aqueduct SED System. This disposable tubing set interfaces with the Aqueduct SED Console (ACCCON100) for monitoring of intracranial pressure (ICP) and draining and monitoring of CSF flow from the lateral ventricles.
AQUEDUCT CRITICAL CARE, INC.
ACC-CART-100
Not in Commercial Distribution

  • ACCCART100 ()


  • Cerebrospinal fluid pressure regulation system sensor/tubing set
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 SIZE 1-3
CARESTREAM HEALTH, INC.
CS 7600 SLOT PANEL
In Commercial Distribution

  • 60889971023704 ()
1023704

  • Dental computed radiography digital imaging scanner
EV SCR, 20PR 15x30cm-Panoramic
CARESTREAM HEALTH, INC.
EV Screens
In Commercial Distribution

  • 60889971015556 ()
1015551

  • X-ray intensifying screen
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 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 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 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
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