i-Clean Temporary Abutment

GUDID 08806169108760

Dental Implant System / i-Clean Temporary Abutment D5.2mm, Cuff2.0mm / PEEK / Non-Octa

DENTIS CO., LTD.

Dental implant suprastructure, permanent, preformed
Primary Device ID08806169108760
NIH Device Record Keyfadbe8c5-806c-4929-bf35-738ccacfc1c7
Commercial Distribution StatusIn Commercial Distribution
Brand Namei-Clean Temporary Abutment
Version Model NumberDIPT20N
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
GS108806169108760 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08806169108760]

Moist Heat or Steam Sterilization


[08806169108760]

Moist Heat or Steam Sterilization


[08806169108760]

Moist Heat or Steam Sterilization


[08806169108760]

Moist Heat or Steam Sterilization


[08806169108760]

Moist Heat or Steam Sterilization


[08806169108760]

Moist Heat or Steam Sterilization


[08806169108760]

Moist Heat or Steam Sterilization


[08806169108760]

Moist Heat or Steam Sterilization


[08806169108760]

Moist Heat or Steam Sterilization


[08806169108760]

Moist Heat or Steam Sterilization


[08806169108760]

Moist Heat or Steam Sterilization


[08806169108760]

Moist Heat or Steam Sterilization


[08806169108760]

Moist Heat or Steam Sterilization


[08806169108760]

Moist Heat or Steam Sterilization


[08806169108760]

Moist Heat or Steam Sterilization


[08806169108760]

Moist Heat or Steam Sterilization


[08806169108760]

Moist Heat or Steam Sterilization


[08806169108760]

Moist Heat or Steam Sterilization


[08806169108760]

Moist Heat or Steam Sterilization


[08806169108760]

Moist Heat or Steam Sterilization


[08806169108760]

Moist Heat or Steam Sterilization


[08806169108760]

Moist Heat or Steam Sterilization


[08806169108760]

Moist Heat or Steam Sterilization


[08806169108760]

Moist Heat or Steam Sterilization


[08806169108760]

Moist Heat or Steam Sterilization


[08806169108760]

Moist Heat or Steam Sterilization


[08806169108760]

Moist Heat or Steam Sterilization


[08806169108760]

Moist Heat or Steam Sterilization


[08806169108760]

Moist Heat or Steam Sterilization


[08806169108760]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-11-08
Device Publish Date2015-08-25

On-Brand Devices [ i-Clean Temporary Abutment ]

08806169100658Dental Implant System / i-Clean Temporary Abutment D5.2mm, Cuff2.0mm / Titanium / Octa
08806169100641Dental Implant System / i-Clean Temporary Abutment D5.2mm, Cuff1.0mm / Titanium / Non-Octa
08806169100634Dental Implant System / i-Clean Temporary Abutment D5.2mm, Cuff1.0mm / Titanium / Octa
08806169108760Dental Implant System / i-Clean Temporary Abutment D5.2mm, Cuff2.0mm / PEEK / Non-Octa

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