i-Clean Closing Screw

GUDID 08806169100139

Dental Implant System / i-Clean Closing Screw D3.5mm X L5.5mm

DENTIS CO., LTD.

Dental implant suprastructure, temporary, preformed, single-use
Primary Device ID08806169100139
NIH Device Record Keydd2a3081-7d34-4e59-8bb8-16915144d96f
Commercial Distribution StatusIn Commercial Distribution
Brand Namei-Clean Closing Screw
Version Model NumberDICS3
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
GS108806169100139 [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 Date2015-07-30

On-Brand Devices [i-Clean Closing Screw]

08806169100139Dental Implant System / i-Clean Closing Screw D3.5mm X L5.5mm
08800053007818Dental Implant System / i-Clean Closing Screw D4.3mm X L5.8mm

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