s-Clean DOA Ball Abutment

GUDID 08806169192202

Dental Implant System / s-Clean DOA Ball Abutment D3.5mm X L15.36mm

DENTIS CO., LTD.

Dental implant suprastructure, permanent, preformed
Primary Device ID08806169192202
NIH Device Record Key7031a17c-fae2-45e2-934e-84139c48cea4
Commercial Distribution StatusIn Commercial Distribution
Brand Names-Clean DOA Ball Abutment
Version Model NumberDSRDBA60
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
GS108806169192202 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08806169192202]

Moist Heat or Steam Sterilization


[08806169192202]

Moist Heat or Steam Sterilization


[08806169192202]

Moist Heat or Steam Sterilization


[08806169192202]

Moist Heat or Steam Sterilization


[08806169192202]

Moist Heat or Steam Sterilization


[08806169192202]

Moist Heat or Steam Sterilization


[08806169192202]

Moist Heat or Steam Sterilization


[08806169192202]

Moist Heat or Steam Sterilization


[08806169192202]

Moist Heat or Steam Sterilization


[08806169192202]

Moist Heat or Steam Sterilization


[08806169192202]

Moist Heat or Steam Sterilization


[08806169192202]

Moist Heat or Steam Sterilization


[08806169192202]

Moist Heat or Steam Sterilization


[08806169192202]

Moist Heat or Steam Sterilization


[08806169192202]

Moist Heat or Steam Sterilization


[08806169192202]

Moist Heat or Steam Sterilization


[08806169192202]

Moist Heat or Steam Sterilization


[08806169192202]

Moist Heat or Steam Sterilization


[08806169192202]

Moist Heat or Steam Sterilization


[08806169192202]

Moist Heat or Steam Sterilization


[08806169192202]

Moist Heat or Steam Sterilization


[08806169192202]

Moist Heat or Steam Sterilization


[08806169192202]

Moist Heat or Steam Sterilization


[08806169192202]

Moist Heat or Steam Sterilization


[08806169192202]

Moist Heat or Steam Sterilization


[08806169192202]

Moist Heat or Steam Sterilization


[08806169192202]

Moist Heat or Steam Sterilization


[08806169192202]

Moist Heat or Steam Sterilization


[08806169192202]

Moist Heat or Steam Sterilization


[08806169192202]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-11-08
Device Publish Date2019-05-31

On-Brand Devices [s-Clean DOA Ball Abutment]

08806169192202Dental Implant System / s-Clean DOA Ball Abutment D3.5mm X L15.36mm
08806169192196Dental Implant System / s-Clean DOA Ball Abutment D3.5mm X L14.36mm
08806169192189Dental Implant System / s-Clean DOA Ball Abutment D3.5mm X L13.36mm
08806169192172Dental Implant System / s-Clean DOA Ball Abutment D3.5mm X L12.36mm
08806169192165Dental Implant System / s-Clean DOA Ball Abutment D3.5mm X L11.36mm
08806169192158Dental Implant System / s-Clean DOA Ball Abutment D3.5mm X L10.36mm

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