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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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Black Triangle Kit - D9498010032

Convenience kit of Bioclear products used in anterior dental restorations.
Bioclear Matrix Systems
Starter
In Commercial Distribution

  • D9498010032 ()


  • Dental implantation depth/angle gauge, reusable
  • Dental abrasive strip, reusable
  • Dental matrix band kit

Power Dental U.S.A., Inc. - D943N8001S00

2 LED HANDPIECE, STERILIZABLE ALL IN ONE, COMPLETE WITH CORDS
Power Dental U.S.A. Inc.
N8001S
Not in Commercial Distribution

  • D943N8001S00 ()
N8001S

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable

N.A. - J011728114000

Lingual/Palatal sheaths „easy in“, closes, for tooth 26-27/47-46
DENTAURUM GmbH & Co.KG
728-114-00
In Commercial Distribution

  • J011728114000 ()
  • J011728114001 ()


  • Orthodontic bracket, metal

N.A. - J011728113000

Lingual/Palatal sheaths „easy in“, closes, for tooth 17-16/36-37
DENTAURUM GmbH & Co.KG
728-113-00
In Commercial Distribution

  • J011728113000 ()
  • J011728113001 ()


  • Orthodontic bracket, metal

Novo Surgical - G586G5548610

ruler, graduated in cm & inches, 19 3/4" (50.0 cm)
NOVO SURGICAL, INC.
G5548-61
In Commercial Distribution

  • G586G5548610 ()
G5548-61

  • Medical ruler, reusable

Novo Surgical - G586G5548060

x-ray scale, graduated in mm, 19 3/4" (50.0 cm)
NOVO SURGICAL, INC.
G5548-06
In Commercial Distribution

  • G586G5548060 ()
G5548-06

  • Medical ruler, reusable

BUTTERFLY BARRIER FILM DSS-58 - H665196001

D Speed film in a protective pouch. 100 per box
Flow X Ray Corporation
19600
In Commercial Distribution

  • H665196001 ()
  • H6651196000 ()


  • Dental x-ray film, non-screen

DTK adhesive assortment - EBRE540011850

DTK adhesive assortment in a double mixing cartridge 5 Parts
bredent GmbH & Co. KG
54001185
In Commercial Distribution

  • EBRE540011859 ()
  • EBRE540011850 ()
54001185

  • Dental repair kit, ceramic

Cinch™ - M595S461S0

Quick Cinch™ Light-Body in Split-Cartridge System (4-Cartridges & Mixing Tips)
PARKELL, INC.
S461S
Not in Commercial Distribution

  • M595S461S1 ()
  • M595S461S0 ()
S461S

  • Silicone dental impression material

Epic® - M595S3600

Universal B2/B3 Epic®-TmpT Composite in 3-gram Syringe
PARKELL, INC.
S360
Not in Commercial Distribution

  • M595S3600 ()
S360

  • Dental composite resin
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