NC Cementable Abutment

GUDID 06947600305873

BIO CONCEPT CO.,LTD

Dental implant system
Primary Device ID06947600305873
NIH Device Record Key338da16e-41db-49ec-bee3-4c487d1b42af
Commercial Distribution StatusIn Commercial Distribution
Brand NameNC Cementable Abutment
Version Model Number131150
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
GS106947600305873 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06947600305873]

Moist Heat or Steam Sterilization


[06947600305873]

Moist Heat or Steam Sterilization


[06947600305873]

Moist Heat or Steam Sterilization


[06947600305873]

Moist Heat or Steam Sterilization


[06947600305873]

Moist Heat or Steam Sterilization


[06947600305873]

Moist Heat or Steam Sterilization


[06947600305873]

Moist Heat or Steam Sterilization


[06947600305873]

Moist Heat or Steam Sterilization


[06947600305873]

Moist Heat or Steam Sterilization


[06947600305873]

Moist Heat or Steam Sterilization


[06947600305873]

Moist Heat or Steam Sterilization


[06947600305873]

Moist Heat or Steam Sterilization


[06947600305873]

Moist Heat or Steam Sterilization


[06947600305873]

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 Cementable Abutment]

06947600305897131170
06947600305880131160
06947600305873131150
06947600305866131140
06947600305859131130
06947600305842131120
06947600305835131110
06947600305828131100
06947600305811131090
06947600305804131080
06947600305798131070
06947600305781131060

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.