i-Clean Cover Screw

GUDID 08806169100122

Dental Implant System / i-Clean Cover Screw D5.2mm X L6.4mm

DENTIS CO., LTD.

Dental implant suprastructure, temporary, preformed, single-use
Primary Device ID08806169100122
NIH Device Record Key4466a534-ed92-4956-9ef2-db79ceb48b78
Commercial Distribution StatusIn Commercial Distribution
Brand Namei-Clean Cover Screw
Version Model NumberDICS1
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
GS108806169100122 [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 Cover Screw]

08806169100252Dental Implant System / i-Clean Cover Screw D6.4mm X L6.4mm
08806169100122Dental Implant System / i-Clean Cover Screw D5.2mm X L6.4mm
08806169105035Dental Implant System / i-Clean Cover Screw D7.4mm X L6.4mm
08806169105028Dental Implant System / i-Clean Cover Screw D7.0mm X L6.4mm

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