Equator Abutment,Φ 6.5mm,GH 1mm

GUDID 06947600302759

BIO CONCEPT Co., Ltd.

Dental implant system
Primary Device ID06947600302759
NIH Device Record Key2e870e9f-e896-4d77-91f9-0db558096ecb
Commercial Distribution StatusIn Commercial Distribution
Brand NameEquator Abutment,Φ 6.5mm,GH 1mm
Version Model Number034210
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
GS106947600302759 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06947600302759]

Moist Heat or Steam Sterilization


[06947600302759]

Moist Heat or Steam Sterilization


[06947600302759]

Moist Heat or Steam Sterilization


[06947600302759]

Moist Heat or Steam Sterilization


[06947600302759]

Moist Heat or Steam Sterilization


[06947600302759]

Moist Heat or Steam Sterilization


[06947600302759]

Moist Heat or Steam Sterilization


[06947600302759]

Moist Heat or Steam Sterilization


[06947600302759]

Moist Heat or Steam Sterilization


[06947600302759]

Moist Heat or Steam Sterilization


[06947600302759]

Moist Heat or Steam Sterilization


[06947600302759]

Moist Heat or Steam Sterilization


[06947600302759]

Moist Heat or Steam Sterilization


[06947600302759]

Moist Heat or Steam Sterilization


[06947600302759]

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 [Equator Abutment,Φ 6.5mm,GH 1mm]

06947600302872034210-1
06947600302759034210

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