I-FIX Angled Type Fixture

GUDID 08806169104465

Dental Implant System / I-FIX Angled Type Fixture D2.5mm X L16.0mm

DENTIS CO., LTD.

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Primary Device ID08806169104465
NIH Device Record Key0d3c4958-b7c4-4eb7-b535-0a6622441e54
Commercial Distribution StatusIn Commercial Distribution
Brand NameI-FIX Angled Type Fixture
Version Model NumberDMAF2516S
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
GS108806169104465 [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 Number4
Public Version Date2019-05-03
Device Publish Date2015-07-31

On-Brand Devices [I-FIX Angled Type Fixture]

08806169104557Dental Implant System / I-FIX Angled Type Fixture D3.0mm X L16.0mm
08806169104540Dental Implant System / I-FIX Angled Type Fixture D3.0mm X L13.0mm
08806169104533Dental Implant System / I-FIX Angled Type Fixture D3.0mm X L10.0mm
08806169104526Dental Implant System / I-FIX Angled Type Fixture D3.0mm X L16.0mm
08806169104519Dental Implant System / I-FIX Angled Type Fixture D3.0mm X L13.0mm
08806169104502Dental Implant System / I-FIX Angled Type Fixture D3.0mm X L10.0mm
08806169104496Dental Implant System / I-FIX Angled Type Fixture D2.5mm X L16.0mm
08806169104489Dental Implant System / I-FIX Angled Type Fixture D2.5mm X L13.0mm
08806169104472Dental Implant System / I-FIX Angled Type Fixture D2.5mm X L10.0mm
08806169104465Dental Implant System / I-FIX Angled Type Fixture D2.5mm X L16.0mm
08806169104458Dental Implant System / I-FIX Angled Type Fixture D2.5mm X L13.0mm
08806169104441Dental Implant System / I-FIX Angled Type Fixture D2.5mm X L10.0mm
08806169104434Dental Implant System / I-FIX Angled Type Fixture D2.0mm X L16.0mm
08806169104427Dental Implant System / I-FIX Angled Type Fixture D2.0mm X L13.0mm
08806169104410Dental Implant System / I-FIX Angled Type Fixture D2.0mm X L10.0mm
08806169104403Dental Implant System / I-FIX Angled Type Fixture D2.0mm X L16.0mm
08806169104397Dental Implant System / I-FIX Angled Type Fixture D2.0mm X L13.0mm
08806169104380Dental Implant System / I-FIX Angled Type Fixture D2.0mm X L10.0mm
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