i-Clean Gold UCLA Abutment

GUDID 08806169109064

Dental Implant System / i-Clean Gold UCLA Abutment Set (Abutment + Abutment Screw)

DENTIS CO., LTD.

Dental implant suprastructure, permanent, preformed
Primary Device ID08806169109064
NIH Device Record Key0d5a5a3f-011f-47de-a49a-68da8b9d488f
Commercial Distribution StatusIn Commercial Distribution
Brand Namei-Clean Gold UCLA Abutment
Version Model NumberDIGUWNS
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
GS108806169109064 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08806169109064]

Moist Heat or Steam Sterilization


[08806169109064]

Moist Heat or Steam Sterilization


[08806169109064]

Moist Heat or Steam Sterilization


[08806169109064]

Moist Heat or Steam Sterilization


[08806169109064]

Moist Heat or Steam Sterilization


[08806169109064]

Moist Heat or Steam Sterilization


[08806169109064]

Moist Heat or Steam Sterilization


[08806169109064]

Moist Heat or Steam Sterilization


[08806169109064]

Moist Heat or Steam Sterilization


[08806169109064]

Moist Heat or Steam Sterilization


[08806169109064]

Moist Heat or Steam Sterilization


[08806169109064]

Moist Heat or Steam Sterilization


[08806169109064]

Moist Heat or Steam Sterilization


[08806169109064]

Moist Heat or Steam Sterilization


[08806169109064]

Moist Heat or Steam Sterilization


[08806169109064]

Moist Heat or Steam Sterilization


[08806169109064]

Moist Heat or Steam Sterilization


[08806169109064]

Moist Heat or Steam Sterilization


[08806169109064]

Moist Heat or Steam Sterilization


[08806169109064]

Moist Heat or Steam Sterilization


[08806169109064]

Moist Heat or Steam Sterilization


[08806169109064]

Moist Heat or Steam Sterilization


[08806169109064]

Moist Heat or Steam Sterilization


[08806169109064]

Moist Heat or Steam Sterilization


[08806169109064]

Moist Heat or Steam Sterilization


[08806169109064]

Moist Heat or Steam Sterilization


[08806169109064]

Moist Heat or Steam Sterilization


[08806169109064]

Moist Heat or Steam Sterilization


[08806169109064]

Moist Heat or Steam Sterilization


[08806169109064]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-11-08
Device Publish Date2019-05-22

On-Brand Devices [i-Clean Gold UCLA Abutment]

08806169100603Dental Implant System / i-Clean Gold UCLA Abutment D5.1mm / Non-Octa
08806169100597Dental Implant System / i-Clean Gold UCLA Abutment D5.1mm / Octa
08806169166081Dental Implant System / i-Clean Gold UCLA Abutment D6.8mm / Non-Octa
08806169166074Dental Implant System / i-Clean Gold UCLA Abutment D6.8mm / Octa
08806169109064Dental Implant System / i-Clean Gold UCLA Abutment Set (Abutment + Abutment Screw)
08806169109057Dental Implant System / i-Clean Gold UCLA Abutment Set (Abutment + Abutment Screw)
08806169166623Dental Implant System / i-Clean Gold UCLA Abutment Set (Abutment + Abutment Screw)
08806169166616Dental Implant System / i-Clean Gold UCLA Abutment Set (Abutment + Abutment Screw)

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