i-Clean InOcta Abutment

GUDID 08806169100481

Dental Implant System / i-Clean InOcta Abutment D6.4mm, Cuff2.0mm / Octa

DENTIS CO., LTD.

Dental implant suprastructure, permanent, preformed
Primary Device ID08806169100481
NIH Device Record Keyb2f5a22e-d696-43b3-bcb6-d2830fcfab7b
Commercial Distribution StatusIn Commercial Distribution
Brand Namei-Clean InOcta Abutment
Version Model NumberDICOS20
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
GS108806169100481 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08806169100481]

Moist Heat or Steam Sterilization


[08806169100481]

Moist Heat or Steam Sterilization


[08806169100481]

Moist Heat or Steam Sterilization


[08806169100481]

Moist Heat or Steam Sterilization


[08806169100481]

Moist Heat or Steam Sterilization


[08806169100481]

Moist Heat or Steam Sterilization


[08806169100481]

Moist Heat or Steam Sterilization


[08806169100481]

Moist Heat or Steam Sterilization


[08806169100481]

Moist Heat or Steam Sterilization


[08806169100481]

Moist Heat or Steam Sterilization


[08806169100481]

Moist Heat or Steam Sterilization


[08806169100481]

Moist Heat or Steam Sterilization


[08806169100481]

Moist Heat or Steam Sterilization


[08806169100481]

Moist Heat or Steam Sterilization


[08806169100481]

Moist Heat or Steam Sterilization


[08806169100481]

Moist Heat or Steam Sterilization


[08806169100481]

Moist Heat or Steam Sterilization


[08806169100481]

Moist Heat or Steam Sterilization


[08806169100481]

Moist Heat or Steam Sterilization


[08806169100481]

Moist Heat or Steam Sterilization


[08806169100481]

Moist Heat or Steam Sterilization


[08806169100481]

Moist Heat or Steam Sterilization


[08806169100481]

Moist Heat or Steam Sterilization


[08806169100481]

Moist Heat or Steam Sterilization


[08806169100481]

Moist Heat or Steam Sterilization


[08806169100481]

Moist Heat or Steam Sterilization


[08806169100481]

Moist Heat or Steam Sterilization


[08806169100481]

Moist Heat or Steam Sterilization


[08806169100481]

Moist Heat or Steam Sterilization


[08806169100481]

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 InOcta Abutment]

08806169100535Dental Implant System / i-Clean InOcta Abutment D6.4mm, Cuff4.0mm / Non-Octa
08806169100528Dental Implant System / i-Clean InOcta Abutment D6.4mm, Cuff4.0mm / Octa
08806169100511Dental Implant System / i-Clean InOcta Abutment D6.4mm, Cuff3.0mm / Non-Octa
08806169100504Dental Implant System / i-Clean InOcta Abutment D6.4mm, Cuff3.0mm / Octa
08806169100498Dental Implant System / i-Clean InOcta Abutment D6.4mm, Cuff2.0mm / Non-Octa
08806169100481Dental Implant System / i-Clean InOcta Abutment D6.4mm, Cuff2.0mm / Octa
08806169100474Dental Implant System / i-Clean InOcta Abutment D6.4mm, Cuff1.0mm / Non-Octa
08806169100467Dental Implant System / i-Clean InOcta Abutment D6.4mm, Cuff1.0mm / Octa
08806169100429Dental Implant System / i-Clean InOcta Abutment D5.2mm, Cuff4.0mm / Non-Octa
08806169100412Dental Implant System / i-Clean InOcta Abutment D5.2mm, Cuff4.0mm / Octa
08806169100405Dental Implant System / i-Clean InOcta Abutment D5.2mm, Cuff3.0mm / Non-Octa
08806169100399Dental Implant System / i-Clean InOcta Abutment D5.2mm, Cuff3.0mm / Octa
08806169100382Dental Implant System / i-Clean InOcta Abutment D5.2mm, Cuff2.0mm / Non-Octa
08806169100375Dental Implant System / i-Clean InOcta Abutment D5.2mm, Cuff2.0mm / Octa
08806169100368Dental Implant System / i-Clean InOcta Abutment D5.2mm, Cuff1.0mm / Non-Octa
08806169100351Dental Implant System / i-Clean InOcta Abutment D5.2mm, Cuff1.0mm / Octa
08806169166388Dental Implant System / i-Clean InOcta Abutment Set (Abutment + Abutment Screw)
08806169166371Dental Implant System / i-Clean InOcta Abutment Set (Abutment + Abutment Screw)
08806169166364Dental Implant System / i-Clean InOcta Abutment Set (Abutment + Abutment Screw)
08806169166357Dental Implant System / i-Clean InOcta Abutment Set (Abutment + Abutment Screw)
08806169166340Dental Implant System / i-Clean InOcta Abutment Set (Abutment + Abutment Screw)
08806169166333Dental Implant System / i-Clean InOcta Abutment Set (Abutment + Abutment Screw)
08806169166326Dental Implant System / i-Clean InOcta Abutment Set (Abutment + Abutment Screw)
08806169166319Dental Implant System / i-Clean InOcta Abutment Set (Abutment + Abutment Screw)
08806169166302Dental Implant System / i-Clean InOcta Abutment Set (Abutment + Abutment Screw)
08806169166296Dental Implant System / i-Clean InOcta Abutment Set (Abutment + Abutment Screw)
08806169166289Dental Implant System / i-Clean InOcta Abutment Set (Abutment + Abutment Screw)
08806169166272Dental Implant System / i-Clean InOcta Abutment Set (Abutment + Abutment Screw)
08806169166265Dental Implant System / i-Clean InOcta Abutment Set (Abutment + Abutment Screw)
08806169166258Dental Implant System / i-Clean InOcta Abutment Set (Abutment + Abutment Screw)
08806169166241Dental Implant System / i-Clean InOcta Abutment Set (Abutment + Abutment Screw)
08806169166234Dental Implant System / i-Clean InOcta Abutment Set (Abutment + Abutment Screw)
08806169165794Dental Implant System / i-Clean InOcta Abutment D6.9mm, Cuff4.0mm / Non-Octa
08806169165787Dental Implant System / i-Clean InOcta Abutment D6.9mm, Cuff3.0mm / Non-Octa
08806169165770Dental Implant System / i-Clean InOcta Abutment D6.9mm, Cuff2.0mm / Non-Octa
08806169165763Dental Implant System / i-Clean InOcta Abutment D6.9mm, Cuff1.0mm / Non-Octa
08806169165671Dental Implant System / i-Clean InOcta Abutment D6.9mm, Cuff4.0mm / Octa
08806169165664Dental Implant System / i-Clean InOcta Abutment D6.9mm, Cuff3.0mm / Octa
08806169165657Dental Implant System / i-Clean InOcta Abutment D6.9mm, Cuff2.0mm / Octa
08806169165640Dental Implant System / i-Clean InOcta Abutment D6.9mm, Cuff1.0mm / Octa
08806169109163Dental Implant System / i-Clean InOcta Abutment Set (Abutment + Abutment Screw)
08806169109156Dental Implant System / i-Clean InOcta Abutment Set (Abutment + Abutment Screw)
08806169109149Dental Implant System / i-Clean InOcta Abutment Set (Abutment + Abutment Screw)
08806169109132Dental Implant System / i-Clean InOcta Abutment Set (Abutment + Abutment Screw)
08806169109125Dental Implant System / i-Clean InOcta Abutment Set (Abutment + Abutment Screw)
08806169109118Dental Implant System / i-Clean InOcta Abutment Set (Abutment + Abutment Screw)
08806169109101Dental Implant System / i-Clean InOcta Abutment Set (Abutment + Abutment Screw)
08806169109095Dental Implant System / i-Clean InOcta Abutment Set (Abutment + Abutment Screw)

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