Cover Screw

GUDID 08800070204924

Izenimplant Co., Ltd.

Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use
Primary Device ID08800070204924
NIH Device Record Key49f983ec-fe50-4f03-b4a8-c89914b26ade
Commercial Distribution StatusIn Commercial Distribution
Brand NameCover Screw
Version Model NumberCSSM30M
Company DUNS694625347
Company NameIzenimplant Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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
GS108800070204924 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-16
Device Publish Date2022-05-06

On-Brand Devices [Cover Screw]

08800070205020CSTR40L
08800070205013CSTR40M
08800070205006CSTR40S
08800070204993CSTM35L
08800070204986CSTM35M
08800070204979CSTM35S
08800070204962CSSR40L
08800070204955CSSR40M
08800070204948CSSR40S
08800070204931CSSM30L
08800070204924CSSM30M
08800070204917CSSM30S
08800070204900CSSN30L
08800070204894CSSN30M
08800070204887CSSN30S
08800070204870CSSX26

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