s-Clean TiN Half Coating Free Abutment

GUDID 08806169115805

Dental Implant System / s-Clean TiN Half Coating Free Abutment Set (Abutment + Abutment Screw)

DENTIS CO., LTD.

Dental implant suprastructure, permanent, preformed
Primary Device ID08806169115805
NIH Device Record Key498bb2c3-65f1-4694-ac74-874d8f4a7c98
Commercial Distribution StatusIn Commercial Distribution
Brand Names-Clean TiN Half Coating Free Abutment
Version Model NumberDSFA55HHCTS
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
GS108806169115805 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08806169115805]

Moist Heat or Steam Sterilization


[08806169115805]

Moist Heat or Steam Sterilization


[08806169115805]

Moist Heat or Steam Sterilization


[08806169115805]

Moist Heat or Steam Sterilization


[08806169115805]

Moist Heat or Steam Sterilization


[08806169115805]

Moist Heat or Steam Sterilization


[08806169115805]

Moist Heat or Steam Sterilization


[08806169115805]

Moist Heat or Steam Sterilization


[08806169115805]

Moist Heat or Steam Sterilization


[08806169115805]

Moist Heat or Steam Sterilization


[08806169115805]

Moist Heat or Steam Sterilization


[08806169115805]

Moist Heat or Steam Sterilization


[08806169115805]

Moist Heat or Steam Sterilization


[08806169115805]

Moist Heat or Steam Sterilization


[08806169115805]

Moist Heat or Steam Sterilization


[08806169115805]

Moist Heat or Steam Sterilization


[08806169115805]

Moist Heat or Steam Sterilization


[08806169115805]

Moist Heat or Steam Sterilization


[08806169115805]

Moist Heat or Steam Sterilization


[08806169115805]

Moist Heat or Steam Sterilization


[08806169115805]

Moist Heat or Steam Sterilization


[08806169115805]

Moist Heat or Steam Sterilization


[08806169115805]

Moist Heat or Steam Sterilization


[08806169115805]

Moist Heat or Steam Sterilization


[08806169115805]

Moist Heat or Steam Sterilization


[08806169115805]

Moist Heat or Steam Sterilization


[08806169115805]

Moist Heat or Steam Sterilization


[08806169115805]

Moist Heat or Steam Sterilization


[08806169115805]

Moist Heat or Steam Sterilization


[08806169115805]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-11-08
Device Publish Date2019-05-30

On-Brand Devices [s-Clean TiN Half Coating Free Abutment]

08806169192424Dental Implant System / s-Clean ZrN Half Coating Free Abutment D5.5mm / Non-Hex / TiN Half Coati
08806169192400Dental Implant System / s-Clean ZrN Half Coating Free Abutment D4.5mm / Non-Hex / TiN Half Coati
08806169192387Dental Implant System / s-Clean ZrN Half Coating Free Abutment D6.5mm / Hex / TiN Half Coating
08806169192363Dental Implant System / s-Clean ZrN Half Coating Free Abutment D5.5mm / Hex / TiN Half Coating
08806169192349Dental Implant System / s-Clean ZrN Half Coating Free Abutment D4.5mm / Hex / TiN Half Coating
08806169115843Dental Implant System / s-Clean TiN Half Coating Free Abutment Set (Abutment + Abutment Screw)
08806169115836Dental Implant System / s-Clean TiN Half Coating Free Abutment Set (Abutment + Abutment Screw)
08806169115829Dental Implant System / s-Clean TiN Half Coating Free Abutment Set (Abutment + Abutment Screw)
08806169115812Dental Implant System / s-Clean TiN Half Coating Free Abutment Set (Abutment + Abutment Screw)
08806169115805Dental Implant System / s-Clean TiN Half Coating Free Abutment Set (Abutment + Abutment Screw)
08806169115799Dental Implant System / s-Clean TiN Half Coating Free Abutment Set (Abutment + Abutment Screw)
08806169192448Dental Implant System / s-Clean ZrN Half Coating Free Abutment D6.5mm / Non-Hex / TiN Half Coati

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