Release Aid N for Mount

GUDID 06947600304234

BIO CONCEPT CO.,LTD

Dental implant system
Primary Device ID06947600304234
NIH Device Record Key45ff1511-953f-4ced-b0a6-5c84bfdecfde
Commercial Distribution StatusIn Commercial Distribution
Brand NameRelease Aid N for Mount
Version Model Number153050
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
GS106947600304234 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06947600304234]

Moist Heat or Steam Sterilization


[06947600304234]

Moist Heat or Steam Sterilization


[06947600304234]

Moist Heat or Steam Sterilization


[06947600304234]

Moist Heat or Steam Sterilization


[06947600304234]

Moist Heat or Steam Sterilization


[06947600304234]

Moist Heat or Steam Sterilization


[06947600304234]

Moist Heat or Steam Sterilization


[06947600304234]

Moist Heat or Steam Sterilization


[06947600304234]

Moist Heat or Steam Sterilization


[06947600304234]

Moist Heat or Steam Sterilization


[06947600304234]

Moist Heat or Steam Sterilization


[06947600304234]

Moist Heat or Steam Sterilization


[06947600304234]

Moist Heat or Steam Sterilization


[06947600304234]

Moist Heat or Steam Sterilization


[06947600304234]

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

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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

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