e-Clean Temporary Abutment

GUDID 08806169103819

Dental Implant System / e-Clean Temporary Abutment D4.5mm X L12.0mm / Titanium / Hex

DENTIS CO., LTD.

Dental implant suprastructure, permanent, preformed
Primary Device ID08806169103819
NIH Device Record Key7cf06cf7-8eea-44bb-b8c6-7c427208f2c2
Commercial Distribution StatusIn Commercial Distribution
Brand Namee-Clean Temporary Abutment
Version Model NumberDETRH
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
GS108806169103819 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08806169103819]

Moist Heat or Steam Sterilization


[08806169103819]

Moist Heat or Steam Sterilization


[08806169103819]

Moist Heat or Steam Sterilization


[08806169103819]

Moist Heat or Steam Sterilization


[08806169103819]

Moist Heat or Steam Sterilization


[08806169103819]

Moist Heat or Steam Sterilization


[08806169103819]

Moist Heat or Steam Sterilization


[08806169103819]

Moist Heat or Steam Sterilization


[08806169103819]

Moist Heat or Steam Sterilization


[08806169103819]

Moist Heat or Steam Sterilization


[08806169103819]

Moist Heat or Steam Sterilization


[08806169103819]

Moist Heat or Steam Sterilization


[08806169103819]

Moist Heat or Steam Sterilization


[08806169103819]

Moist Heat or Steam Sterilization


[08806169103819]

Moist Heat or Steam Sterilization


[08806169103819]

Moist Heat or Steam Sterilization


[08806169103819]

Moist Heat or Steam Sterilization


[08806169103819]

Moist Heat or Steam Sterilization


[08806169103819]

Moist Heat or Steam Sterilization


[08806169103819]

Moist Heat or Steam Sterilization


[08806169103819]

Moist Heat or Steam Sterilization


[08806169103819]

Moist Heat or Steam Sterilization


[08806169103819]

Moist Heat or Steam Sterilization


[08806169103819]

Moist Heat or Steam Sterilization


[08806169103819]

Moist Heat or Steam Sterilization


[08806169103819]

Moist Heat or Steam Sterilization


[08806169103819]

Moist Heat or Steam Sterilization


[08806169103819]

Moist Heat or Steam Sterilization


[08806169103819]

Moist Heat or Steam Sterilization


[08806169103819]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-11-08
Device Publish Date2015-08-31

On-Brand Devices [e-Clean Temporary Abutment]

08806169103840Dental Implant System / e-Clean Temporary Abutment D5.5mm X L12.0mm / Titanium / Non-Hex
08806169103833Dental Implant System / e-Clean Temporary Abutment D5.5mm X L12.0mm / Titanium / Hex
08806169103826Dental Implant System / e-Clean Temporary Abutment D4.5mm X L12.0mm / Titanium / Non-Hex
08806169103819Dental Implant System / e-Clean Temporary Abutment D4.5mm X L12.0mm / Titanium / Hex
08806169103802Dental Implant System / e-Clean Temporary Abutment D4.0mm X L12.0mm / Titanium / Non-Hex
08806169103796Dental Implant System / e-Clean Temporary Abutment D4.0mm X L12.0mm / Titanium / Hex

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