Bone Level Tapered Implant

GUDID 06947600303060

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 Dental implant system
Primary Device ID06947600303060
NIH Device Record Key254be5a3-8d00-4028-8b2c-92370d92ffae
Commercial Distribution StatusIn Commercial Distribution
Brand NameBone Level Tapered Implant
Version Model Number115030
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 Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106947600303060 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-08
Device Publish Date2022-08-31

On-Brand Devices [Bone Level Tapered Implant]

06947600303213117060
06947600303206117050
06947600303190117040
06947600303183117030
06947600303176117020
06947600303169117010
06947600303152116060
06947600303145116050
06947600303138116040
06947600303121116030
06947600303114116020
06947600303107116010
06947600303091115060
06947600303084115050
06947600303077115040
06947600303060115030
06947600303053115020
06947600303046115010

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