I-FIX O-Ring Type Fixture

GUDID 08806169104182

Dental Implant System / I-FIX O-Ring Type Fixture D2.0mm X L16.0mm

DENTIS CO., LTD.

Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece
Primary Device ID08806169104182
NIH Device Record Keyda301c8a-1304-43e3-9928-93981118e00d
Commercial Distribution StatusIn Commercial Distribution
Brand NameI-FIX O-Ring Type Fixture
Version Model NumberDMOF2016L
Company DUNS688204158
Company NameDENTIS CO., LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108806169104182 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-05-08
Device Publish Date2015-07-31

On-Brand Devices [I-FIX O-Ring Type Fixture]

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08806169104298Dental Implant System / I-FIX O-Ring Type Fixture D3.0mm X L13.0mm
08806169104281Dental Implant System / I-FIX O-Ring Type Fixture D3.0mm X L10.0mm
08806169104274Dental Implant System / I-FIX O-Ring Type Fixture D3.0mm X L16.0mm
08806169104267Dental Implant System / I-FIX O-Ring Type Fixture D3.0mm X L13.0mm
08806169104250Dental Implant System / I-FIX O-Ring Type Fixture D3.0mm X L10.0mm
08806169104243Dental Implant System / I-FIX O-Ring Type Fixture D2.5mm X L16.0mm
08806169104236Dental Implant System / I-FIX O-Ring Type Fixture D2.5mm X L13.0mm
08806169104229Dental Implant System / I-FIX O-Ring Type Fixture D2.5mm X L10.0mm
08806169104212Dental Implant System / I-FIX O-Ring Type Fixture D2.5mm X L16.0mm
08806169104205Dental Implant System / I-FIX O-Ring Type Fixture D2.5mm X L13.0mm
08806169104199Dental Implant System / I-FIX O-Ring Type Fixture D2.5mm X L10.0mm
08806169104182Dental Implant System / I-FIX O-Ring Type Fixture D2.0mm X L16.0mm
08806169104175Dental Implant System / I-FIX O-Ring Type Fixture D2.0mm X L13.0mm
08806169104168Dental Implant System / I-FIX O-Ring Type Fixture D2.0mm X L10.0mm
08806169104151Dental Implant System / I-FIX O-Ring Type Fixture D2.0mm X L16.0mm
08806169104144Dental Implant System / I-FIX O-Ring Type Fixture D2.0mm X L13.0mm
08806169104137Dental Implant System / I-FIX O-Ring Type Fixture D2.0mm X L10.0mm
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