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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Malar Sizer Set
IMPLANTECH ASSOCIATES, INC.
900-010
In Commercial Distribution

  • M7249000101 ()
900-010

  • Malar prosthesis
Dental polymerization activator
Guilin Woodpecker Medical Instrument Co., Ltd.
i Led II
In Commercial Distribution

  • 06944843605722 ()


  • Dental/surgical polymerization lamp
Dental polymerization activator
Guilin Woodpecker Medical Instrument Co., Ltd.
i Led II
In Commercial Distribution

  • 06944843605715 ()


  • Dental/surgical polymerization lamp
Electronic Apex Locator is used to support the dentist in the determination of the working length during the endodontic treatment.
Shenzhen Superline Technology Co., Ltd.
Alpha Apex I
In Commercial Distribution

  • 01069448351999 ()
  • 06944835199918 ()


  • Endodontic apex locator
Preform Abutment
NT-Trading GmbH & Co. KG
I 10.Mi4.100
Not in Commercial Distribution

  • ENTTI10MI41001 ()

  • Preform Abutment Diameter: Ø 4.1 mm; gingiva height 1.3 mm; compatible with implant system: Biomet 3i®, Osseotite®


  • Dental implant suprastructure, permanent, preformed
Preform Abutment
NT-Trading GmbH & Co. KG
I 10.Mi4.100.05
Not in Commercial Distribution

  • ENTTI10MI4100051 ()

  • Preform Abutment Diameter: Ø 4.1 mm; gingiva height 0.5 mm; compatible with implant system: Biomet 3i®, Osseotite®


  • Dental implant suprastructure, permanent, preformed
[Simcoe] Double Barrel I/A Cannula 23g/23g X 16mm (5/8”), side port
Psi/Eye-Ko, Inc.
3003A
In Commercial Distribution

  • 00840516120225 ()
  • 00840516116303 ()
  • 00840516124094 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
[Simcoe] Double Barrel I/A Cannula 23g/23g X 16mm (5/8”), side port
Psi/Eye-Ko, Inc.
3003A
In Commercial Distribution

  • 00840516104935 ()
  • 00840516113371 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Seibel I IntraLase flap lifter/retreatment spatula, 4 1/2'', double-ended, round handle, titanium
AMBLER SURGICAL CORP.
Seibel I IntraLase flap lifter/retreatment spatula
In Commercial Distribution

  • 00190660175993 ()
6905T

  • Ocular hook/spatula/manipulator, reusable
CHISEL, OSTEOTOME SET OST SET I / BONE CONDENSING SET BY DR. HOHL & DR. HILDEBRAND
Helmut Zepf Medizintechnik GmbH
47.949.90
In Commercial Distribution

  • EZPF47949900 ()
47.949.90

  • Periosteal elevator, reusable
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