Implant, Regular, Φ7.0mm, L15mm

GUDID 06947600313915

BIO CONCEPT Co., Ltd.

Dental implant system
Primary Device ID06947600313915
NIH Device Record Keyd7c03d81-298a-4a0e-bd6a-66cd2a18b786
Commercial Distribution StatusIn Commercial Distribution
Brand NameImplant, Regular, Φ7.0mm, L15mm
Version Model Number316070
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
GS106947600313915 [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 Date2025-03-28
Device Publish Date2025-03-20

Devices Manufactured by BIO CONCEPT Co., Ltd.

06947600302698 - Equator Abutment,Φ 4.8mm,GH 1mm2025-03-28
06947600302704 - Equator Abutment,Φ 4.8mm,GH 2mm2025-03-28
06947600302711 - Equator Abutment,Φ 4.8mm,GH 3mm2025-03-28
06947600302728 - Equator Abutment,Φ 4.8mm,GH 4mm2025-03-28
06947600302735 - Equator Abutment,Φ 4.8mm,GH 5mm2025-03-28
06947600302742 - Equator Abutment,Φ 4.8mm,GH 6mm2025-03-28
06947600302759 - Equator Abutment,Φ 6.5mm,GH 1mm2025-03-28
06947600302766 - Equator Abutment,Φ 6.5mm,GH 2mm2025-03-28

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