i-Clean SynOcta Abutment

GUDID 08806169113504

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

DENTIS CO., LTD.

Dental implant suprastructure, permanent, preformed
Primary Device ID08806169113504
NIH Device Record Key15f9758a-d1ea-4ae0-8951-0d64841d9a9c
Commercial Distribution StatusIn Commercial Distribution
Brand Namei-Clean SynOcta Abutment
Version Model NumberDISOWA485OS
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
GS108806169113504 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08806169113504]

Moist Heat or Steam Sterilization


[08806169113504]

Moist Heat or Steam Sterilization


[08806169113504]

Moist Heat or Steam Sterilization


[08806169113504]

Moist Heat or Steam Sterilization


[08806169113504]

Moist Heat or Steam Sterilization


[08806169113504]

Moist Heat or Steam Sterilization


[08806169113504]

Moist Heat or Steam Sterilization


[08806169113504]

Moist Heat or Steam Sterilization


[08806169113504]

Moist Heat or Steam Sterilization


[08806169113504]

Moist Heat or Steam Sterilization


[08806169113504]

Moist Heat or Steam Sterilization


[08806169113504]

Moist Heat or Steam Sterilization


[08806169113504]

Moist Heat or Steam Sterilization


[08806169113504]

Moist Heat or Steam Sterilization


[08806169113504]

Moist Heat or Steam Sterilization


[08806169113504]

Moist Heat or Steam Sterilization


[08806169113504]

Moist Heat or Steam Sterilization


[08806169113504]

Moist Heat or Steam Sterilization


[08806169113504]

Moist Heat or Steam Sterilization


[08806169113504]

Moist Heat or Steam Sterilization


[08806169113504]

Moist Heat or Steam Sterilization


[08806169113504]

Moist Heat or Steam Sterilization


[08806169113504]

Moist Heat or Steam Sterilization


[08806169113504]

Moist Heat or Steam Sterilization


[08806169113504]

Moist Heat or Steam Sterilization


[08806169113504]

Moist Heat or Steam Sterilization


[08806169113504]

Moist Heat or Steam Sterilization


[08806169113504]

Moist Heat or Steam Sterilization


[08806169113504]

Moist Heat or Steam Sterilization


[08806169113504]

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 SynOcta Abutment]

08806169100450Dental Implant System / i-Clean SynOcta Abutment D3.5mm, Post Height6.0mm / Non-Octa
08806169100443Dental Implant System / i-Clean SynOcta Abutment D3.5mm, Post Height6.0mm / Octa
08806169113542Dental Implant System / i-Clean SynOcta Abutment Set (Abutment + Abutment Screw)
08806169113535Dental Implant System / i-Clean SynOcta Abutment Set (Abutment + Abutment Screw)
08806169113528Dental Implant System / i-Clean SynOcta Abutment Set (Abutment + Abutment Screw)
08806169113511Dental Implant System / i-Clean SynOcta Abutment Set (Abutment + Abutment Screw)
08806169113504Dental Implant System / i-Clean SynOcta Abutment Set (Abutment + Abutment Screw)
08806169113498Dental Implant System / i-Clean SynOcta Abutment Set (Abutment + Abutment Screw)
08806169112910Dental Implant System / i-Clean SynOcta Abutment Set (Abutment + Abutment Screw)
08806169112903Dental Implant System / i-Clean SynOcta Abutment Set (Abutment + Abutment Screw)
08806169166227Dental Implant System / i-Clean SynOcta Abutment Set (Abutment + Abutment Screw)
08806169166210Dental Implant System / i-Clean SynOcta Abutment Set (Abutment + Abutment Screw)

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