Implant, Regular

GUDID 06947600314776

BIO CONCEPT CO.,LTD

Dental implant system
Primary Device ID06947600314776
NIH Device Record Key2753e1ee-0e9c-4059-bc90-ee53c60cee48
Commercial Distribution StatusIn Commercial Distribution
Brand NameImplant, Regular
Version Model Number312050G
Company DUNS527603266
Company NameBIO CONCEPT 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
GS106947600314776 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-29
Device Publish Date2024-11-21

On-Brand Devices [Implant, Regular]

06947600317999316060G
06947600317982316050G
06947600317975316040G
06947600317968316030G
06947600317951316020G
06947600317944315060G
06947600317937315050G
06947600317920315040G
06947600317913315030G
06947600317906315020G
06947600314967314070G
06947600314950314060G
06947600314943314050G
06947600314936314040G
06947600314929314030G
06947600314912314020G
06947600314905313060G
06947600314899313050G
06947600314882313040G
06947600314875313030G
06947600314868313020G
06947600314851313010G
06947600314844312060G
06947600314837312020G
06947600314820312010G
06947600314776312050G
06947600314721312040G
06947600314714312030G

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