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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 NANO SYRINGE 4.5 Gm (B2) - D77819930050

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

SCOTT'S SELECT NANO SYRINGE 4.5 Gm (A3.5) - D77819930040

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

SCOTT'S SELECT NANO SYRINGE 4.5 Gm (A3) - D77819930030

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

SCOTT'S SELECT NANO SYRINGE 4.5 Gm (A2) - D77819930020

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

SCOTT'S SELECT NANO SYRINGE 4.5 Gm (A1) - D77819930010

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

Onyx HD 500 - 00836462005129

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

  • 00836462005129 ()


  • Neurovascular embolization plug

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

Renamel® Flowable Microhybrid - EDEL7011A20

Renamel® Flowable Microhybrid Body A2, Syringe 3g
DeltaMed GmbH
7011A2
In Commercial Distribution

7011A2

  • Dental composite resin

Renamel® Flowable Microhybrid - EDEL70110W0

Renamel® Flowable Microhybrid Body White, Syringe 3g
DeltaMed GmbH
70110W
In Commercial Distribution

70110W

  • Dental composite resin

Renamel® Bulkfill - EDEL6722C31

Renamel® Bulkfill C3, 20 Compules
DeltaMed GmbH
6722C3
In Commercial Distribution

  • EDEL6722C30 ()
  • EDEL6722C31 ()
  • D7796722C31 ()
6722C3

  • Dental composite resin

Renamel® Bulkfill - EDEL6722B01

Renamel® Bulkfill B-Zero, 20 Compules
DeltaMed GmbH
6722B0
In Commercial Distribution

  • EDEL6722B00 ()
  • EDEL6722B01 ()
  • D7796722B01 ()
6722B0

  • Dental composite resin

Renamel® Bulkfill - EDEL6722A31

Renamel® Bulkfill A3, 20 Compules
DeltaMed GmbH
6722A3
In Commercial Distribution

  • EDEL6722A30 ()
  • EDEL6722A31 ()
  • D7796722A31 ()
6722A3

  • Dental composite resin

Renamel® Bulkfill - EDEL6722A21

Renamel® Bulkfill A2, 20 Compules
DeltaMed GmbH
6722A2
In Commercial Distribution

  • EDEL6722A20 ()
  • EDEL6722A21 ()
  • D7796722A21 ()
6722A2

  • Dental composite resin

Renamel® Bulkfill - EDEL6722A11

Renamel® Bulkfill A1, 20 Compules
DeltaMed GmbH
6722A1
In Commercial Distribution

  • EDEL6722A10 ()
  • EDEL6722A11 ()
  • D7796722A11 ()
6722A1

  • Dental composite resin

Brush & Sculpt™ - EDEL6271010

Brush & Sculpt™, Syringe 1g
DeltaMed GmbH
627101
In Commercial Distribution

627101

  • Dental composite resin

Insure® UNIVERSAL AutoMix - EDEL625AML0

Insure® UNIVERSAL AutoMix Yellow Red Light, Syringe 8g
DeltaMed GmbH
625AML
In Commercial Distribution

  • EDEL625AML0 ()
625AML

  • Dental composite resin

Insure® UNIVERSAL AutoMix - EDEL625AMC0

Insure® UNIVERSAL AutoMix Clear, Syringe 8g
DeltaMed GmbH
625AMC
In Commercial Distribution

  • EDEL625AMC0 ()
625AMC

  • Dental composite resin

Insure® UNIVERSAL - EDEL6251060

Insure® UNIVERSAL Yellow Opaque, Syringe 3g
DeltaMed GmbH
625106
In Commercial Distribution

  • EDEL6251060 ()
625106

  • Dental composite resin

Insure® UNIVERSAL - EDEL6251040

Insure® UNIVERSAL Grey Light, Syringe 3g
DeltaMed GmbH
625104
In Commercial Distribution

  • EDEL6251040 ()
625104

  • Dental composite resin

Insure® UNIVERSAL - EDEL6251020

Insure® UNIVERSAL Yellow Red Light, Syringe 3g
DeltaMed GmbH
625102
In Commercial Distribution

  • EDEL6251020 ()
625102

  • Dental composite resin

CosmeCore™ - EDEL6227A20

CosmeCore™ A2, Syringe 8g
DeltaMed GmbH
6227A2
In Commercial Distribution

6227A2

  • Dental composite resin

CosmeCore™ - EDEL62270B0

CosmeCore™ Blue, Syringe 8g
DeltaMed GmbH
62270B
In Commercial Distribution

62270B

  • Dental composite resin

CosmeCore™ - EDEL62210W0

CosmeCore™ White, Syringe 50g
DeltaMed GmbH
62210W
In Commercial Distribution

62210W

  • Dental composite resin

CosmeCore™ - EDEL62210B0

CosmeCore™ Blue, Syringe 50g
DeltaMed GmbH
62210B
In Commercial Distribution

62210B

  • Dental composite resin

COSMESEAL™ Clear - EDEL6170CL0

COSMESEAL® Clear, Syringe 1g
DeltaMed GmbH
6170CL
In Commercial Distribution

6170CL

  • Dental composite resin

Renamel® Microhybrid - EDEL616A350

Renamel® Microhybrid Body A3.5, Syringe 2g
DeltaMed GmbH
616A35
Not in Commercial Distribution

616A35

  • Dental composite resin

Renamel® Microhybrid - EDEL6161D30

Renamel® Microhybrid Body D3, Syringe 2g
DeltaMed GmbH
6161D3
Not in Commercial Distribution

6161D3

  • Dental composite resin

Renamel® Microhybrid - EDEL6161D20

Renamel® Microhybrid Body D2, Syringe 2g
DeltaMed GmbH
6161D2
Not in Commercial Distribution

6161D2

  • Dental composite resin

Renamel® Microhybrid - EDEL6161CO0

Renamel® Microhybrid Clear Occlusal, Syringe 2g
DeltaMed GmbH
6161CO
Not in Commercial Distribution

6161CO

  • Dental composite resin

Renamel® Microhybrid - EDEL6161C40

Renamel® Microhybrid Body C4, Syringe 2g
DeltaMed GmbH
6161C4
Not in Commercial Distribution

6161C4

  • Dental composite resin

Renamel® Microhybrid - EDEL6161C30

Renamel® Microhybrid Body C3, Syringe 2g
DeltaMed GmbH
6161C3
Not in Commercial Distribution

6161C3

  • Dental composite resin

Renamel® Microhybrid - EDEL6161C20

Renamel® Microhybrid Body C2, Syringe 2g
DeltaMed GmbH
6161C2
Not in Commercial Distribution

6161C2

  • Dental composite resin

Renamel® Microhybrid - EDEL6161C10

Renamel® Microhybrid Body C1, Syringe 2g
DeltaMed GmbH
6161C1
Not in Commercial Distribution

6161C1

  • Dental composite resin

Renamel® Microhybrid - EDEL6161B20

Renamel® Microhybrid Body B2, Syringe 2g
DeltaMed GmbH
6161B2
Not in Commercial Distribution

6161B2

  • Dental composite resin

Renamel® Microhybrid - EDEL6161B10

Renamel® Microhybrid Body B1, Syringe 2g
DeltaMed GmbH
6161B1
Not in Commercial Distribution

6161B1

  • Dental composite resin

Renamel® Microhybrid - EDEL6161B00

Renamel® Microhybrid Body B-Zero, Syringe 2g
DeltaMed GmbH
6161B0
Not in Commercial Distribution

6161B0

  • Dental composite resin

Renamel® Microhybrid - EDEL6161A40

Renamel® Microhybrid Body A4, Syringe 2g
DeltaMed GmbH
6161A4
Not in Commercial Distribution

6161A4

  • Dental composite resin

Renamel® Microhybrid - EDEL6161A30

Renamel® Microhybrid Body A3, Syringe 2g
DeltaMed GmbH
6161A3
Not in Commercial Distribution

6161A3

  • Dental composite resin

Renamel® Microhybrid - EDEL6161A10

Renamel® Microhybrid Body A1, Syringe 2g
DeltaMed GmbH
6161A1
Not in Commercial Distribution

6161A1

  • Dental composite resin

Renamel® Microfill - EDEL615SB10

Renamel® Microfill SuperBrite 1, Syringe 2g
DeltaMed GmbH
615SB1
Not in Commercial Distribution

615SB1

  • Dental composite resin

Renamel® Microfill - EDEL615A250

Renamel® Microfill Enamel Body A2.5, Syringe 2g
DeltaMed GmbH
615A25
Not in Commercial Distribution

615A25

  • Dental composite resin

Renamel® Microfill - EDEL6151MI0

Renamel® Microfill Enamel Medium Incisal, Syringe 2g
DeltaMed GmbH
6151MI
Not in Commercial Distribution

6151MI

  • Dental composite resin

Renamel® Microfill - EDEL6151D30

Renamel® Microfill Enamel Body D3, Syringe 2g
DeltaMed GmbH
6151D3
Not in Commercial Distribution

6151D3

  • Dental composite resin

Renamel® Microfill - EDEL6151C40

Renamel® Microfill Enamel Body C4, Syringe 2g
DeltaMed GmbH
6151C4
Not in Commercial Distribution

6151C4

  • Dental composite resin

Renamel® Microfill - EDEL6151C20

Renamel® Microfill Enamel Body C2, Syringe 2g
DeltaMed GmbH
6151C2
Not in Commercial Distribution

6151C2

  • Dental composite resin

Renamel® Microfill - EDEL6151BO0

Renamel® Microfill Enamel Body B-Zero, Syringe 2g
DeltaMed GmbH
6151BO
Not in Commercial Distribution

6151BO

  • Dental composite resin

Renamel® Microfill - EDEL6151B20

Renamel® Microfill Enamel Body B2, Syringe 2g
DeltaMed GmbH
6151B2
Not in Commercial Distribution

6151B2

  • Dental composite resin
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