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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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GLUMA DESENSITIZER 1 X 5 ML - J014658723540

Agent, tooth bonding resin
Kulzer GmbH
65872354
In Commercial Distribution

  • J014658723540 ()
65872354

  • Dentine bonding agent/set

DYNAMIX MIXING TIPS (1 X 50) - J014600359991

Dental Composite resin
Kulzer GmbH
60035999
In Commercial Distribution

  • J014600359991 ()
60035999

  • Dental composite resin

DYNAMIX MIXING TIPS (1 X 50) - J014600359990

Material Impression
Kulzer GmbH
60035999
Not in Commercial Distribution

  • J014600359990 ()
60035999

  • Polyether dental impression material

VENUS SYR 1 x 4G - OC3 - J014660076020

crown & bridge, temporary, resin
Kulzer GmbH
66007602
Not in Commercial Distribution

  • J014660076020 ()
66007602

  • Temporary dental crown/bridge

DYNAMIX MIXING TIPS (1 X 50) - J014400043530

Syringe, restortative and impression material
Kulzer GmbH
40004353
In Commercial Distribution

  • J014400043530 ()
40004353

  • Polyether dental impression material

CHARISMA SYR 1 x 4G - C3 - J014660000940

Dental Composite resin
Kulzer GmbH
66000094
In Commercial Distribution

  • J014660000940 ()
66000094

  • Dental composite resin

Premium X thin blue Articulating Paper - D04060001140

A strip or sheet of suitable material coated with pigment and used for marking areas of contact between opposite teeth, restorations or appliances. This is a single-use device
WHIP-MIX CORPORATION
Premium Strips
In Commercial Distribution

  • D04060001140 ()
60001

  • Dental articulation paper

ITOTAL-IPOLY-44MM X 11MM CEMENTED PATELLA IMPLANT - M572PAT0114411011

No Description
Conformis, Inc.
PAT011441101
In Commercial Distribution

  • M572PAT0114411011 ()

  • 44MM X 11MM
PAT0114411

  • Polyethylene patella prosthesis

osteo-WEDGE Temporary Tack 2.4mm x 12mm - M621OW24TT12MM0

osteo-WEDGE Temporary Tack, 2.4mm x 12mm. Non-sterile single use (disposable) accessory for use with the osteo-WEDGE Opening Wedge Bone Locking Plate System. The osteo-WEDGE Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization and/or correction of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations.
Gramedica
GM-100-12
In Commercial Distribution

  • M621OW24TT12MM0 ()

  • 2.4mm x 12mm
OW2.4TT-12MM

  • Orthopaedic fixation plate, non-bioabsorbable

Titanschraube M 1,4 x 7 mm - EBRE991000120

Titanschraube M 1,4 x 7 mm
bredent GmbH & Co. KG
99100012
In Commercial Distribution

  • EBRE991000129 ()
  • EBRE991000120 ()
99100012

  • Screw endosteal dental implant, two-piece
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