I-FIX Post Type Fixture

GUDID 08806169103963

Dental Implant System / I-FIX Post Type Fixture D2.0mm X L13.0mm

DENTIS CO., LTD.

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Primary Device ID08806169103963
NIH Device Record Keyc65dea3e-d3e1-45a8-ad0a-c7fbf437d3f6
Commercial Distribution StatusIn Commercial Distribution
Brand NameI-FIX Post Type Fixture
Version Model NumberDMPF2013S
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 Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108806169103963 [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 Post Type Fixture]

08806169104120Dental Implant System / I-FIX Post Type Fixture D3.0mm X L16.0mm
08806169104106Dental Implant System / I-FIX Post Type Fixture D3.0mm X L10.0mm
08806169104090Dental Implant System / I-FIX Post Type Fixture D3.0mm X L16.0mm
08806169104083Dental Implant System / I-FIX Post Type Fixture D3.0mm X L13.0mm
08806169104076Dental Implant System / I-FIX Post Type Fixture D3.0mm X L10.0mm
08806169104069Dental Implant System / I-FIX Post Type Fixture D2.5mm X L16.0mm
08806169104052Dental Implant System / I-FIX Post Type Fixture D2.5mm X L13.0mm
08806169104045Dental Implant System / I-FIX Post Type Fixture D2.5mm X L10.0mm
08806169104038Dental Implant System / I-FIX Post Type Fixture D2.5mm X L16.0mm
08806169104021Dental Implant System / I-FIX Post Type Fixture D2.5mm X L13.0mm
08806169104014Dental Implant System / I-FIX Post Type Fixture D2.5mm X L10.0mm
08806169104007Dental Implant System / I-FIX Post Type Fixture D2.0mm X L16.0mm
08806169103994Dental Implant System / I-FIX Post Type Fixture D2.0mm X L13.0mm
08806169103987Dental Implant System / I-FIX Post Type Fixture D2.0mm X L10.0mm
08806169103970Dental Implant System / I-FIX Post Type Fixture D2.0mm X L16.0mm
08806169103963Dental Implant System / I-FIX Post Type Fixture D2.0mm X L13.0mm
08806169103956Dental Implant System / I-FIX Post Type Fixture D2.0mm X L10.0mm
08806169104113Ø3.0x13mm
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