Bone Level Implant

GUDID 06947600305033

BIO CONCEPT CO.,LTD

Dental implant system
Primary Device ID06947600305033
NIH Device Record Keya9dafdc3-714e-4857-9faf-e0402b893aec
Commercial Distribution StatusIn Commercial Distribution
Brand NameBone Level Implant
Version Model Number111020
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
GS106947600305033 [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 [Bone Level Implant]

06947600305231113040
06947600305217113030
06947600305194113020
06947600305170113010
06947600305156112040
06947600305132112030
06947600305118112020
06947600305095112010
06947600305071111040
06947600305057111030
06947600305033111020
06947600305019111010

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