e-Clean Cover Screw

GUDID 08806169102874

Dental Implant System / e-Clean Cover Screw D5.4mm X L5.9mm

DENTIS CO., LTD.

Dental implant suprastructure, temporary, preformed, single-use
Primary Device ID08806169102874
NIH Device Record Key87f79d7c-3d4c-4b19-997a-762b3b7b58bb
Commercial Distribution StatusIn Commercial Distribution
Brand Namee-Clean Cover Screw
Version Model NumberDECSW
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108806169102874 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-05-08
Device Publish Date2015-07-31

On-Brand Devices [e-Clean Cover Screw]

08806169102874Dental Implant System / e-Clean Cover Screw D5.4mm X L5.9mm
08806169102867Dental Implant System / e-Clean Cover Screw D4.3mm X L5.9mm
08806169102850Dental Implant System / e-Clean Cover Screw D3.8mm X L5.9mm

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