s-Clean O-Ring Abutment

GUDID 08806169102683

Dental Implant System / s-Clean O-Ring Abutment D3.4mm Cuff0.3mm

DENTIS CO., LTD.

Dental implant suprastructure, permanent, preformed
Primary Device ID08806169102683
NIH Device Record Key78f02670-16fe-44cf-8450-c1f0c5a9995b
Commercial Distribution StatusIn Commercial Distribution
Brand Names-Clean O-Ring Abutment
Version Model NumberDSORA00
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
GS108806169102683 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08806169102683]

Moist Heat or Steam Sterilization


[08806169102683]

Moist Heat or Steam Sterilization


[08806169102683]

Moist Heat or Steam Sterilization


[08806169102683]

Moist Heat or Steam Sterilization


[08806169102683]

Moist Heat or Steam Sterilization


[08806169102683]

Moist Heat or Steam Sterilization


[08806169102683]

Moist Heat or Steam Sterilization


[08806169102683]

Moist Heat or Steam Sterilization


[08806169102683]

Moist Heat or Steam Sterilization


[08806169102683]

Moist Heat or Steam Sterilization


[08806169102683]

Moist Heat or Steam Sterilization


[08806169102683]

Moist Heat or Steam Sterilization


[08806169102683]

Moist Heat or Steam Sterilization


[08806169102683]

Moist Heat or Steam Sterilization


[08806169102683]

Moist Heat or Steam Sterilization


[08806169102683]

Moist Heat or Steam Sterilization


[08806169102683]

Moist Heat or Steam Sterilization


[08806169102683]

Moist Heat or Steam Sterilization


[08806169102683]

Moist Heat or Steam Sterilization


[08806169102683]

Moist Heat or Steam Sterilization


[08806169102683]

Moist Heat or Steam Sterilization


[08806169102683]

Moist Heat or Steam Sterilization


[08806169102683]

Moist Heat or Steam Sterilization


[08806169102683]

Moist Heat or Steam Sterilization


[08806169102683]

Moist Heat or Steam Sterilization


[08806169102683]

Moist Heat or Steam Sterilization


[08806169102683]

Moist Heat or Steam Sterilization


[08806169102683]

Moist Heat or Steam Sterilization


[08806169102683]

Moist Heat or Steam Sterilization


[08806169102683]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-11-08
Device Publish Date2015-08-31

On-Brand Devices [s-Clean O-Ring Abutment]

08806169102706Dental Implant System / s-Clean O-Ring Abutment D4.5mm Cuff3.8mm
08806169102690Dental Implant System / s-Clean O-Ring Abutment D4.5mm Cuff1.8mm
08806169102683Dental Implant System / s-Clean O-Ring Abutment D3.4mm Cuff0.3mm
08806169131805Dental Implant System / s-Clean O-Ring Abutment D3.5mm X L12.0mm
08806169131799Dental Implant System / s-Clean O-Ring Abutment D3.5mm X L10.0mm

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