Bone Level Implant Profile drill

GUDID 06947600306511

BIO CONCEPT CO.,LTD

Dental implant system
Primary Device ID06947600306511
NIH Device Record Key9a59d027-a962-4754-9ade-07616692f866
Commercial Distribution StatusIn Commercial Distribution
Brand NameBone Level Implant Profile drill
Version Model Number150110
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 Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106947600306511 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06947600306511]

Moist Heat or Steam Sterilization


[06947600306511]

Moist Heat or Steam Sterilization


[06947600306511]

Moist Heat or Steam Sterilization


[06947600306511]

Moist Heat or Steam Sterilization


[06947600306511]

Moist Heat or Steam Sterilization


[06947600306511]

Moist Heat or Steam Sterilization


[06947600306511]

Moist Heat or Steam Sterilization


[06947600306511]

Moist Heat or Steam Sterilization


[06947600306511]

Moist Heat or Steam Sterilization


[06947600306511]

Moist Heat or Steam Sterilization


[06947600306511]

Moist Heat or Steam Sterilization


[06947600306511]

Moist Heat or Steam Sterilization


[06947600306511]

Moist Heat or Steam Sterilization


[06947600306511]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-11-19
Device Publish Date2016-09-01

On-Brand Devices [Bone Level Implant Profile drill]

06947600306528150120
06947600306511150110
06947600306498150090
06947600306481150080
06947600306467150060
06947600306450150050

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