RC Cem. Abutment

GUDID 06947600306214

BIO CONCEPT CO.,LTD

Dental implant system
Primary Device ID06947600306214
NIH Device Record Key1127d2d5-8a7b-47e0-b93f-2bd31c4886e5
Commercial Distribution StatusIn Commercial Distribution
Brand NameRC Cem. Abutment
Version Model Number132160
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
GS106947600306214 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06947600306214]

Moist Heat or Steam Sterilization


[06947600306214]

Moist Heat or Steam Sterilization


[06947600306214]

Moist Heat or Steam Sterilization


[06947600306214]

Moist Heat or Steam Sterilization


[06947600306214]

Moist Heat or Steam Sterilization


[06947600306214]

Moist Heat or Steam Sterilization


[06947600306214]

Moist Heat or Steam Sterilization


[06947600306214]

Moist Heat or Steam Sterilization


[06947600306214]

Moist Heat or Steam Sterilization


[06947600306214]

Moist Heat or Steam Sterilization


[06947600306214]

Moist Heat or Steam Sterilization


[06947600306214]

Moist Heat or Steam Sterilization


[06947600306214]

Moist Heat or Steam Sterilization


[06947600306214]

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 Cem. Abutment]

06947600306221132170
06947600306214132160
06947600306207132150
06947600306191132140
06947600306184132130
06947600306177132120
06947600306160132110
06947600306153132100
06947600306146132090
06947600306139132080
06947600306122132070
06947600306115132060

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