NC Multi-base Abutment

GUDID 06947600306009

BIO CONCEPT CO.,LTD

Dental implant system
Primary Device ID06947600306009
NIH Device Record Keyd2934a9d-4a10-4a8b-bc24-dc710efd490c
Commercial Distribution StatusIn Commercial Distribution
Brand NameNC Multi-base Abutment
Version Model Number131280
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
GS106947600306009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06947600306009]

Moist Heat or Steam Sterilization


[06947600306009]

Moist Heat or Steam Sterilization


[06947600306009]

Moist Heat or Steam Sterilization


[06947600306009]

Moist Heat or Steam Sterilization


[06947600306009]

Moist Heat or Steam Sterilization


[06947600306009]

Moist Heat or Steam Sterilization


[06947600306009]

Moist Heat or Steam Sterilization


[06947600306009]

Moist Heat or Steam Sterilization


[06947600306009]

Moist Heat or Steam Sterilization


[06947600306009]

Moist Heat or Steam Sterilization


[06947600306009]

Moist Heat or Steam Sterilization


[06947600306009]

Moist Heat or Steam Sterilization


[06947600306009]

Moist Heat or Steam Sterilization


[06947600306009]

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 [NC Multi-base Abutment]

06947600306054131330
06947600306047131320
06947600306030131310
06947600306023131300
06947600306016131290
06947600306009131280
06947600305996131270
06947600305989131260

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