Depth Gauge, with Distance Indicator

GUDID 06947600304197

BIO CONCEPT CO.,LTD

Dental implant system
Primary Device ID06947600304197
NIH Device Record Keyc99f3e29-e415-47c6-9947-c6947ac9359e
Commercial Distribution StatusIn Commercial Distribution
Brand NameDepth Gauge, with Distance Indicator
Version Model Number152020
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 Usefalse
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
GS106947600304197 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06947600304197]

Moist Heat or Steam Sterilization


[06947600304197]

Moist Heat or Steam Sterilization


[06947600304197]

Moist Heat or Steam Sterilization


[06947600304197]

Moist Heat or Steam Sterilization


[06947600304197]

Moist Heat or Steam Sterilization


[06947600304197]

Moist Heat or Steam Sterilization


[06947600304197]

Moist Heat or Steam Sterilization


[06947600304197]

Moist Heat or Steam Sterilization


[06947600304197]

Moist Heat or Steam Sterilization


[06947600304197]

Moist Heat or Steam Sterilization


[06947600304197]

Moist Heat or Steam Sterilization


[06947600304197]

Moist Heat or Steam Sterilization


[06947600304197]

Moist Heat or Steam Sterilization


[06947600304197]

Moist Heat or Steam Sterilization


[06947600304197]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-13
Device Publish Date2022-09-05

Devices Manufactured by BIO CONCEPT CO.,LTD

06947600316596 - BV Guided Kit,BV2024-09-26
06947600319016 - Anchor Drill,Φ1.3mm,L33mm2024-09-26
06947600319030 - Initial Drill,Φ3.5mm/Φ5.7mm,L5mm2024-09-26
06947600319047 - Initial Drill,Φ2.7mm/Φ5mm,L5mm2024-09-26
06947600319054 - Initial Drill,Φ3.5mm/Φ5mm,L5mm2024-09-26
06947600319061 - Initial Drill,Φ2.7mm/Φ5mm,L7mm2024-09-26
06947600319078 - Initial Drill,Φ2.7mm/Φ5mm,L8.5mm2024-09-26
06947600319085 - Initial Drill,Φ2.7mm/Φ5mm,L10mm2024-09-26

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