RN Octagon angled Abutment

GUDID 06947600301271

BIO CONCEPT CO.,LTD

Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system
Primary Device ID06947600301271
NIH Device Record Keyb3ea9cd8-a765-4451-a12c-accd8af80eeb
Commercial Distribution StatusIn Commercial Distribution
Brand NameRN Octagon angled Abutment
Version Model Number032140
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
GS106947600301271 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06947600301271]

Moist Heat or Steam Sterilization


[06947600301271]

Moist Heat or Steam Sterilization


[06947600301271]

Moist Heat or Steam Sterilization


[06947600301271]

Moist Heat or Steam Sterilization


[06947600301271]

Moist Heat or Steam Sterilization


[06947600301271]

Moist Heat or Steam Sterilization


[06947600301271]

Moist Heat or Steam Sterilization


[06947600301271]

Moist Heat or Steam Sterilization


[06947600301271]

Moist Heat or Steam Sterilization


[06947600301271]

Moist Heat or Steam Sterilization


[06947600301271]

Moist Heat or Steam Sterilization


[06947600301271]

Moist Heat or Steam Sterilization


[06947600301271]

Moist Heat or Steam Sterilization


[06947600301271]

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 [RN Octagon angled Abutment]

06947600301295032160
06947600301288032150
06947600301271032140
06947600301264032130
06947600301257032120
06947600301240032110
06947600301233032100
06947600301226032090

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