I-FIX Angled Type Mount Adapt Screw

GUDID 08806169132437

Dental Implant System / I-FIX Angled Type Mount Adapter Screw D1.9mm X L5.6mm

DENTIS CO., LTD.

Dental implant suprastructure, temporary, preformed, single-use
Primary Device ID08806169132437
NIH Device Record Key49a91cb0-dc56-405c-944b-f122fa782635
Commercial Distribution StatusIn Commercial Distribution
Brand NameI-FIX Angled Type Mount Adapt Screw
Version Model NumberDMAMS
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108806169132437 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08806169132437]

Moist Heat or Steam Sterilization


[08806169132437]

Moist Heat or Steam Sterilization


[08806169132437]

Moist Heat or Steam Sterilization


[08806169132437]

Moist Heat or Steam Sterilization


[08806169132437]

Moist Heat or Steam Sterilization


[08806169132437]

Moist Heat or Steam Sterilization


[08806169132437]

Moist Heat or Steam Sterilization


[08806169132437]

Moist Heat or Steam Sterilization


[08806169132437]

Moist Heat or Steam Sterilization


[08806169132437]

Moist Heat or Steam Sterilization


[08806169132437]

Moist Heat or Steam Sterilization


[08806169132437]

Moist Heat or Steam Sterilization


[08806169132437]

Moist Heat or Steam Sterilization


[08806169132437]

Moist Heat or Steam Sterilization


[08806169132437]

Moist Heat or Steam Sterilization


[08806169132437]

Moist Heat or Steam Sterilization


[08806169132437]

Moist Heat or Steam Sterilization


[08806169132437]

Moist Heat or Steam Sterilization


[08806169132437]

Moist Heat or Steam Sterilization


[08806169132437]

Moist Heat or Steam Sterilization


[08806169132437]

Moist Heat or Steam Sterilization


[08806169132437]

Moist Heat or Steam Sterilization


[08806169132437]

Moist Heat or Steam Sterilization


[08806169132437]

Moist Heat or Steam Sterilization


[08806169132437]

Moist Heat or Steam Sterilization


[08806169132437]

Moist Heat or Steam Sterilization


[08806169132437]

Moist Heat or Steam Sterilization


[08806169132437]

Moist Heat or Steam Sterilization


[08806169132437]

Moist Heat or Steam Sterilization


[08806169132437]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-05-20
Device Publish Date2019-05-10

Devices Manufactured by DENTIS CO., LTD.

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08806169155979 - s-Clean SQ-SL Fixture2020-05-01 s-Clean SQ-SL Fixture / D4.1 X L7.0 mm
08806169155986 - s-Clean SQ-SL Fixture2020-05-01 s-Clean SQ-SL Fixture / D4.1mm X L7.5mm
08806169155993 - s-Clean SQ-SL Fixture2020-05-01 s-Clean SQ-SL Fixture / D4.1mm X L9.5mm
08806169156006 - s-Clean SQ-SL Fixture2020-05-01 s-Clean SQ-SL Fixture / D4.1mm X L11.5mm
08806169156013 - s-Clean SQ-SL Fixture2020-05-01 s-Clean SQ-SL Fixture / D4.1mm X L13.5mm
08806169156020 - s-Clean SQ-SL Fixture2020-05-01 s-Clean SQ-SL Fixture / D4.4mm X L7.0mm

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