Standard Plus Implant

GUDID 06947600300007

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 ID06947600300007
NIH Device Record Key18e0e270-dc3e-4991-9196-bf97e847f794
Commercial Distribution Discontinuation2018-12-05
Commercial Distribution StatusNot in Commercial Distribution
Brand NameStandard Plus Implant
Version Model Number011010
Company DUNS527603266
Company NameBIO CONCEPT CO.,LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numbertrue
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106947600300007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-12-05
Device Publish Date2016-06-07

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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