Standard Plus Implant

GUDID 06947600300083

BIO CONCEPT CO.,LTD

Dental implant system
Primary Device ID06947600300083
NIH Device Record Keyebb112d7-eae5-4894-b04f-ae21e6c528ec
Commercial Distribution StatusIn Commercial Distribution
Brand NameStandard Plus Implant
Version Model Number012040
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106947600300083 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

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 [Standard Plus Implant]

06947600300229012180
06947600300212012170
06947600300205012160
06947600300182012140
06947600300175012130
06947600300168012120
06947600300151012110
06947600300137012090
06947600300120012080
06947600300113012070
06947600300106012060
06947600300083012040
06947600300076012030
06947600300069012020
06947600300052012010
06947600300045011040
06947600300038011030
06947600300021011020
06947600300014011010
06947600300007011010

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