e-Clean Abutment Screw

GUDID 08806169102836

Dental Implant System / e-Clean Abutment Screw D2.5mm X L7.1mm / Regular

DENTIS CO., LTD.

Dental prosthesis/implant abutment screw
Primary Device ID08806169102836
NIH Device Record Keye54b2494-e96c-412f-9072-4d8e1e44f196
Commercial Distribution StatusIn Commercial Distribution
Brand Namee-Clean Abutment Screw
Version Model NumberDEASRH
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
GS108806169102836 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08806169102836]

Moist Heat or Steam Sterilization


[08806169102836]

Moist Heat or Steam Sterilization


[08806169102836]

Moist Heat or Steam Sterilization


[08806169102836]

Moist Heat or Steam Sterilization


[08806169102836]

Moist Heat or Steam Sterilization


[08806169102836]

Moist Heat or Steam Sterilization


[08806169102836]

Moist Heat or Steam Sterilization


[08806169102836]

Moist Heat or Steam Sterilization


[08806169102836]

Moist Heat or Steam Sterilization


[08806169102836]

Moist Heat or Steam Sterilization


[08806169102836]

Moist Heat or Steam Sterilization


[08806169102836]

Moist Heat or Steam Sterilization


[08806169102836]

Moist Heat or Steam Sterilization


[08806169102836]

Moist Heat or Steam Sterilization


[08806169102836]

Moist Heat or Steam Sterilization


[08806169102836]

Moist Heat or Steam Sterilization


[08806169102836]

Moist Heat or Steam Sterilization


[08806169102836]

Moist Heat or Steam Sterilization


[08806169102836]

Moist Heat or Steam Sterilization


[08806169102836]

Moist Heat or Steam Sterilization


[08806169102836]

Moist Heat or Steam Sterilization


[08806169102836]

Moist Heat or Steam Sterilization


[08806169102836]

Moist Heat or Steam Sterilization


[08806169102836]

Moist Heat or Steam Sterilization


[08806169102836]

Moist Heat or Steam Sterilization


[08806169102836]

Moist Heat or Steam Sterilization


[08806169102836]

Moist Heat or Steam Sterilization


[08806169102836]

Moist Heat or Steam Sterilization


[08806169102836]

Moist Heat or Steam Sterilization


[08806169102836]

Moist Heat or Steam Sterilization


[08806169102836]

Moist Heat or Steam Sterilization


[08806169102836]

Moist Heat or Steam Sterilization


[08806169102836]

Moist Heat or Steam Sterilization


[08806169102836]

Moist Heat or Steam Sterilization


[08806169102836]

Moist Heat or Steam Sterilization


[08806169102836]

Moist Heat or Steam Sterilization


[08806169102836]

Moist Heat or Steam Sterilization


[08806169102836]

Moist Heat or Steam Sterilization


[08806169102836]

Moist Heat or Steam Sterilization


[08806169102836]

Moist Heat or Steam Sterilization


[08806169102836]

Moist Heat or Steam Sterilization


[08806169102836]

Moist Heat or Steam Sterilization


[08806169102836]

Moist Heat or Steam Sterilization


[08806169102836]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-05-08
Device Publish Date2015-07-31

On-Brand Devices [e-Clean Abutment Screw]

08806169103246Dental Implant System / e-Clean Abutment Screw D2.5mm X L7.8mm / Mini
08806169102843Dental Implant System / e-Clean Abutment Screw D2.9mm X L7.8mm / Wide
08806169102836Dental Implant System / e-Clean Abutment Screw D2.5mm X L7.1mm / Regular

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.