Multi Abutment, Mini

GUDID 06947600317593

BIO CONCEPT CO.,LTD

Dental implant system
Primary Device ID06947600317593
NIH Device Record Keyd3710010-f743-442d-b1ef-bc153f41009a
Commercial Distribution StatusIn Commercial Distribution
Brand NameMulti Abutment, Mini
Version Model Number337040U
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 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
GS106947600317593 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06947600317593]

Moist Heat or Steam Sterilization


[06947600317593]

Moist Heat or Steam Sterilization


[06947600317593]

Moist Heat or Steam Sterilization


[06947600317593]

Moist Heat or Steam Sterilization


[06947600317593]

Moist Heat or Steam Sterilization


[06947600317593]

Moist Heat or Steam Sterilization


[06947600317593]

Moist Heat or Steam Sterilization


[06947600317593]

Moist Heat or Steam Sterilization


[06947600317593]

Moist Heat or Steam Sterilization


[06947600317593]

Moist Heat or Steam Sterilization


[06947600317593]

Moist Heat or Steam Sterilization


[06947600317593]

Moist Heat or Steam Sterilization


[06947600317593]

Moist Heat or Steam Sterilization


[06947600317593]

Moist Heat or Steam Sterilization


[06947600317593]

Moist Heat or Steam Sterilization


[06947600317593]

Moist Heat or Steam Sterilization


[06947600317593]

Moist Heat or Steam Sterilization


[06947600317593]

Moist Heat or Steam Sterilization


[06947600317593]

Moist Heat or Steam Sterilization


[06947600317593]

Moist Heat or Steam Sterilization


[06947600317593]

Moist Heat or Steam Sterilization


[06947600317593]

Moist Heat or Steam Sterilization


[06947600317593]

Moist Heat or Steam Sterilization


[06947600317593]

Moist Heat or Steam Sterilization


[06947600317593]

Moist Heat or Steam Sterilization


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 [Multi Abutment, Mini]

06947600317609337050U
06947600317593337040U
06947600317586337030U
06947600317579337020U
06947600317562337010U

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.