Standard Implant

GUDID 06947600300373

BIO CONCEPT CO.,LTD

Dental implant system
Primary Device ID06947600300373
NIH Device Record Keye42ad6fc-8765-4380-9531-17f8ab8ed387
Commercial Distribution StatusIn Commercial Distribution
Brand NameStandard Implant
Version Model Number013150
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
GS106947600300373 [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 Implant]

06947600300427013200
06947600300410013190
06947600300403013180
06947600300380013160
06947600300373013150
06947600300366013140
06947600300359013130
06947600300335013110
06947600300328013100
06947600300311013090
06947600300304013080
06947600300298013070
06947600300274013050
06947600300267013040
06947600300250013030
06947600300243013020
06947600300236013010

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