Regular Scanbody for oral

GUDID 06947600314523

BIO CONCEPT CO.,LTD

Dental implant abutment analog, scanning
Primary Device ID06947600314523
NIH Device Record Key4fca991b-f5ef-4515-a07f-8ebe5e2f5d09
Commercial Distribution StatusIn Commercial Distribution
Brand NameRegular Scanbody for oral
Version Model Number362570
Company DUNS527603266
Company NameBIO CONCEPT CO.,LTD
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106947600314523 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06947600314523]

Moist Heat or Steam Sterilization


[06947600314523]

Moist Heat or Steam Sterilization


[06947600314523]

Moist Heat or Steam Sterilization


[06947600314523]

Moist Heat or Steam Sterilization


[06947600314523]

Moist Heat or Steam Sterilization


[06947600314523]

Moist Heat or Steam Sterilization


[06947600314523]

Moist Heat or Steam Sterilization


[06947600314523]

Moist Heat or Steam Sterilization


[06947600314523]

Moist Heat or Steam Sterilization


[06947600314523]

Moist Heat or Steam Sterilization


[06947600314523]

Moist Heat or Steam Sterilization


[06947600314523]

Moist Heat or Steam Sterilization


[06947600314523]

Moist Heat or Steam Sterilization


[06947600314523]

Moist Heat or Steam Sterilization


[06947600314523]

Moist Heat or Steam Sterilization


[06947600314523]

Moist Heat or Steam Sterilization


[06947600314523]

Moist Heat or Steam Sterilization


[06947600314523]

Moist Heat or Steam Sterilization


[06947600314523]

Moist Heat or Steam Sterilization


[06947600314523]

Moist Heat or Steam Sterilization


[06947600314523]

Moist Heat or Steam Sterilization


[06947600314523]

Moist Heat or Steam Sterilization


[06947600314523]

Moist Heat or Steam Sterilization


[06947600314523]

Moist Heat or Steam Sterilization


[06947600314523]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-29
Device Publish Date2024-11-21

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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