RC Anatomic Abutment

GUDID 06947600306061

BIO CONCEPT CO.,LTD

Dental implant system
Primary Device ID06947600306061
NIH Device Record Keyca34e35b-d5ef-471a-ad7a-e28ac9084b87
Commercial Distribution StatusIn Commercial Distribution
Brand NameRC Anatomic Abutment
Version Model Number132010
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
GS106947600306061 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06947600306061]

Moist Heat or Steam Sterilization


[06947600306061]

Moist Heat or Steam Sterilization


[06947600306061]

Moist Heat or Steam Sterilization


[06947600306061]

Moist Heat or Steam Sterilization


[06947600306061]

Moist Heat or Steam Sterilization


[06947600306061]

Moist Heat or Steam Sterilization


[06947600306061]

Moist Heat or Steam Sterilization


[06947600306061]

Moist Heat or Steam Sterilization


[06947600306061]

Moist Heat or Steam Sterilization


[06947600306061]

Moist Heat or Steam Sterilization


[06947600306061]

Moist Heat or Steam Sterilization


[06947600306061]

Moist Heat or Steam Sterilization


[06947600306061]

Moist Heat or Steam Sterilization


[06947600306061]

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 [RC Anatomic Abutment]

06947600306092132040
06947600306085132030
06947600306078132020
06947600306061132010

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