i-Clean Octa Abutment

GUDID 08806169112088

Dental Implant System / i-Clean Octa Abutment Set (Abutment + Healing Cap + Cylinder Screw)

DENTIS CO., LTD.

Dental implant suprastructure, permanent, preformed
Primary Device ID08806169112088
NIH Device Record Key29681d42-7a70-411f-9cc8-a0bcd6e9e465
Commercial Distribution StatusIn Commercial Distribution
Brand Namei-Clean Octa Abutment
Version Model NumberDIOAWS
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
GS108806169112088 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08806169112088]

Moist Heat or Steam Sterilization


[08806169112088]

Moist Heat or Steam Sterilization


[08806169112088]

Moist Heat or Steam Sterilization


[08806169112088]

Moist Heat or Steam Sterilization


[08806169112088]

Moist Heat or Steam Sterilization


[08806169112088]

Moist Heat or Steam Sterilization


[08806169112088]

Moist Heat or Steam Sterilization


[08806169112088]

Moist Heat or Steam Sterilization


[08806169112088]

Moist Heat or Steam Sterilization


[08806169112088]

Moist Heat or Steam Sterilization


[08806169112088]

Moist Heat or Steam Sterilization


[08806169112088]

Moist Heat or Steam Sterilization


[08806169112088]

Moist Heat or Steam Sterilization


[08806169112088]

Moist Heat or Steam Sterilization


[08806169112088]

Moist Heat or Steam Sterilization


[08806169112088]

Moist Heat or Steam Sterilization


[08806169112088]

Moist Heat or Steam Sterilization


[08806169112088]

Moist Heat or Steam Sterilization


[08806169112088]

Moist Heat or Steam Sterilization


[08806169112088]

Moist Heat or Steam Sterilization


[08806169112088]

Moist Heat or Steam Sterilization


[08806169112088]

Moist Heat or Steam Sterilization


[08806169112088]

Moist Heat or Steam Sterilization


[08806169112088]

Moist Heat or Steam Sterilization


[08806169112088]

Moist Heat or Steam Sterilization


[08806169112088]

Moist Heat or Steam Sterilization


[08806169112088]

Moist Heat or Steam Sterilization


[08806169112088]

Moist Heat or Steam Sterilization


[08806169112088]

Moist Heat or Steam Sterilization


[08806169112088]

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 Octa Abutment]

08806169100566Dental Implant System / i-Clean Octa Abutment D3.5mm X L7.0mm
08806169165503Dental Implant System / i-Clean Octa Abutment D4.3mm X L7.3mm
08806169112088Dental Implant System / i-Clean Octa Abutment Set (Abutment + Healing Cap + Cylinder Screw)
08806169166203Dental Implant System / i-Clean Octa Abutment Set (Abutment + Healing Cap + Cylinder Screw)

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