Implant Regular

GUDID 06947600310099

BIO CONCEPT CO.,LTD

Dental implant system
Primary Device ID06947600310099
NIH Device Record Keyd7b66bcf-bb5d-4ca2-80da-4700161bea6d
Commercial Distribution StatusIn Commercial Distribution
Brand NameImplant Regular
Version Model Number312040
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
GS106947600310099 [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 Date2020-07-17
Device Publish Date2020-07-09

On-Brand Devices [Implant Regular]

06947600313908316060
06947600313892316050
06947600313885316040
06947600313878316030
06947600313861316020
06947600313830315060
06947600313823315050
06947600313816315040
06947600313809315030
06947600313793315020
06947600310242314070
06947600310235314060
06947600310228314050
06947600310211314040
06947600310204314030
06947600310198314020
06947600310174313060
06947600310167313050
06947600310150313040
06947600310143313030
06947600310136313020
06947600310129313010
06947600310112312060
06947600310105312050
06947600310099312040
06947600310082312030
06947600310075312020
06947600310068312010

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