Equator Impression Transfer

GUDID 06947600314417

BIO CONCEPT CO.,LTD

Dental implant system
Primary Device ID06947600314417
NIH Device Record Key51333533-26ee-4b9f-b96a-7f96f1d6e6f3
Commercial Distribution StatusIn Commercial Distribution
Brand NameEquator Impression Transfer
Version Model Number368010
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106947600314417 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-20
Device Publish Date2020-07-10

Devices Manufactured by BIO CONCEPT CO.,LTD

06947600309055 - Scanbody for screw-retained abutment2024-11-29
06947600309079 - Scanbody for screw-retained abutment2024-11-29
06947600309109 - BLNC Digital Analog2024-11-29
06947600309116 - BLRC Digital Analog2024-11-29
06947600309123 - TLRN Digital Analog2024-11-29
06947600309130 - TLWN Digital Analog2024-11-29
06947600309147 - BL3.5 Screw-retained Abutment Digital Analog2024-11-29
06947600309154 - BL4.6 Screw-retained Abutment Digital Analog2024-11-29

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