i-Clean Angled Abutment

GUDID 08806169105110

Dental Implant System / i-Clean Angled Abutment D5.2mm X L9.55, Angulation20° / Octa

DENTIS CO., LTD.

Dental implant suprastructure, permanent, preformed
Primary Device ID08806169105110
NIH Device Record Key5cbac8f2-dbd4-4d57-9ae0-0dd32ebf6ee9
Commercial Distribution StatusIn Commercial Distribution
Brand Namei-Clean Angled Abutment
Version Model NumberSIAA20
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
GS108806169105110 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08806169105110]

Moist Heat or Steam Sterilization


[08806169105110]

Moist Heat or Steam Sterilization


[08806169105110]

Moist Heat or Steam Sterilization


[08806169105110]

Moist Heat or Steam Sterilization


[08806169105110]

Moist Heat or Steam Sterilization


[08806169105110]

Moist Heat or Steam Sterilization


[08806169105110]

Moist Heat or Steam Sterilization


[08806169105110]

Moist Heat or Steam Sterilization


[08806169105110]

Moist Heat or Steam Sterilization


[08806169105110]

Moist Heat or Steam Sterilization


[08806169105110]

Moist Heat or Steam Sterilization


[08806169105110]

Moist Heat or Steam Sterilization


[08806169105110]

Moist Heat or Steam Sterilization


[08806169105110]

Moist Heat or Steam Sterilization


[08806169105110]

Moist Heat or Steam Sterilization


[08806169105110]

Moist Heat or Steam Sterilization


[08806169105110]

Moist Heat or Steam Sterilization


[08806169105110]

Moist Heat or Steam Sterilization


[08806169105110]

Moist Heat or Steam Sterilization


[08806169105110]

Moist Heat or Steam Sterilization


[08806169105110]

Moist Heat or Steam Sterilization


[08806169105110]

Moist Heat or Steam Sterilization


[08806169105110]

Moist Heat or Steam Sterilization


[08806169105110]

Moist Heat or Steam Sterilization


[08806169105110]

Moist Heat or Steam Sterilization


[08806169105110]

Moist Heat or Steam Sterilization


[08806169105110]

Moist Heat or Steam Sterilization


[08806169105110]

Moist Heat or Steam Sterilization


[08806169105110]

Moist Heat or Steam Sterilization


[08806169105110]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-11-08
Device Publish Date2015-07-30

On-Brand Devices [i-Clean Angled Abutment]

08806169104571Dental Implant System / i-Clean Angled Abutment D3.7mm X L9.4mm, Angulation25° / Octa
08806169104564Dental Implant System / i-Clean Angled Abutment D3.7mm X L9.4mm, Angulation15° / Octa
08806169105110Dental Implant System / i-Clean Angled Abutment D5.2mm X L9.55, Angulation20° / Octa

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