i-Clean Free Abutment

GUDID 08806169100542

Dental Implant System / i-Clean Free Abutment D5.2mm X L13.5mm / Octa

DENTIS CO., LTD.

Dental implant suprastructure, permanent, preformed
Primary Device ID08806169100542
NIH Device Record Keyff1b2acb-4320-450a-bb74-741ef6f5b0f6
Commercial Distribution StatusIn Commercial Distribution
Brand Namei-Clean Free Abutment
Version Model NumberDIFAO
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
GS108806169100542 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08806169100542]

Moist Heat or Steam Sterilization


[08806169100542]

Moist Heat or Steam Sterilization


[08806169100542]

Moist Heat or Steam Sterilization


[08806169100542]

Moist Heat or Steam Sterilization


[08806169100542]

Moist Heat or Steam Sterilization


[08806169100542]

Moist Heat or Steam Sterilization


[08806169100542]

Moist Heat or Steam Sterilization


[08806169100542]

Moist Heat or Steam Sterilization


[08806169100542]

Moist Heat or Steam Sterilization


[08806169100542]

Moist Heat or Steam Sterilization


[08806169100542]

Moist Heat or Steam Sterilization


[08806169100542]

Moist Heat or Steam Sterilization


[08806169100542]

Moist Heat or Steam Sterilization


[08806169100542]

Moist Heat or Steam Sterilization


[08806169100542]

Moist Heat or Steam Sterilization


[08806169100542]

Moist Heat or Steam Sterilization


[08806169100542]

Moist Heat or Steam Sterilization


[08806169100542]

Moist Heat or Steam Sterilization


[08806169100542]

Moist Heat or Steam Sterilization


[08806169100542]

Moist Heat or Steam Sterilization


[08806169100542]

Moist Heat or Steam Sterilization


[08806169100542]

Moist Heat or Steam Sterilization


[08806169100542]

Moist Heat or Steam Sterilization


[08806169100542]

Moist Heat or Steam Sterilization


[08806169100542]

Moist Heat or Steam Sterilization


[08806169100542]

Moist Heat or Steam Sterilization


[08806169100542]

Moist Heat or Steam Sterilization


[08806169100542]

Moist Heat or Steam Sterilization


[08806169100542]

Moist Heat or Steam Sterilization


[08806169100542]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-11-08
Device Publish Date2015-08-21

On-Brand Devices [ i-Clean Free Abutment]

08806169100559Dental Implant System / i-Clean Free Abutment D5.2mm X L13.5mm / Non-Octa
08806169100542Dental Implant System / i-Clean Free Abutment D5.2mm X L13.5mm / Octa

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