Temporary Abutment,H9mm,bridge

GUDID 06947600302988

BIO CONCEPT Co., Ltd.

Dental implant system
Primary Device ID06947600302988
NIH Device Record Key7f149eba-4617-45e2-8d40-4103d7fc1a80
Commercial Distribution StatusIn Commercial Distribution
Brand NameTemporary Abutment,H9mm,bridge
Version Model Number073010N
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
GS106947600302988 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06947600302988]

Moist Heat or Steam Sterilization


[06947600302988]

Moist Heat or Steam Sterilization


[06947600302988]

Moist Heat or Steam Sterilization


[06947600302988]

Moist Heat or Steam Sterilization


[06947600302988]

Moist Heat or Steam Sterilization


[06947600302988]

Moist Heat or Steam Sterilization


[06947600302988]

Moist Heat or Steam Sterilization


[06947600302988]

Moist Heat or Steam Sterilization


[06947600302988]

Moist Heat or Steam Sterilization


[06947600302988]

Moist Heat or Steam Sterilization


[06947600302988]

Moist Heat or Steam Sterilization


[06947600302988]

Moist Heat or Steam Sterilization


[06947600302988]

Moist Heat or Steam Sterilization


[06947600302988]

Moist Heat or Steam Sterilization


[06947600302988]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-28
Device Publish Date2025-03-20

On-Brand Devices [Temporary Abutment,H9mm,bridge]

06947600302988073010N
06947600302964072010N

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