O-Ring Abutment

GUDID 08806169105134

Ø5.0, L:8.2mm

DENTIS CO., LTD.

Dental implant suprastructure, permanent, preformed
Primary Device ID08806169105134
NIH Device Record Key708e4e41-18bd-42d2-9b64-b3f09881d114
Commercial Distribution Discontinuation2019-05-03
Commercial Distribution StatusNot in Commercial Distribution
Brand NameO-Ring Abutment
Version Model NumberDEORRA00
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
GS108806169105134 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08806169105134]

Moist Heat or Steam Sterilization


[08806169105134]

Moist Heat or Steam Sterilization


[08806169105134]

Moist Heat or Steam Sterilization


[08806169105134]

Moist Heat or Steam Sterilization


[08806169105134]

Moist Heat or Steam Sterilization


[08806169105134]

Moist Heat or Steam Sterilization


[08806169105134]

Moist Heat or Steam Sterilization


[08806169105134]

Moist Heat or Steam Sterilization


[08806169105134]

Moist Heat or Steam Sterilization


[08806169105134]

Moist Heat or Steam Sterilization


[08806169105134]

Moist Heat or Steam Sterilization


[08806169105134]

Moist Heat or Steam Sterilization


[08806169105134]

Moist Heat or Steam Sterilization


[08806169105134]

Moist Heat or Steam Sterilization


[08806169105134]

Moist Heat or Steam Sterilization


[08806169105134]

Moist Heat or Steam Sterilization


[08806169105134]

Moist Heat or Steam Sterilization


[08806169105134]

Moist Heat or Steam Sterilization


[08806169105134]

Moist Heat or Steam Sterilization


[08806169105134]

Moist Heat or Steam Sterilization


[08806169105134]

Moist Heat or Steam Sterilization


[08806169105134]

Moist Heat or Steam Sterilization


[08806169105134]

Moist Heat or Steam Sterilization


[08806169105134]

Moist Heat or Steam Sterilization


[08806169105134]

Moist Heat or Steam Sterilization


[08806169105134]

Moist Heat or Steam Sterilization


[08806169105134]

Moist Heat or Steam Sterilization


[08806169105134]

Moist Heat or Steam Sterilization


[08806169105134]

Moist Heat or Steam Sterilization


[08806169105134]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-11-08
Device Publish Date2015-07-30

Devices Manufactured by DENTIS CO., LTD.

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08800053022385 - s-Clean SQ-SL Fixture2021-03-08 Dental Implant System / s-Clean SQ-SL Fixture (DSSFR5507)
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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