TCR Multi 756224

GUDID 07630813462325

TCR Multi D2 98.5-20MM

Candulor AG

Resin artificial teeth
Primary Device ID07630813462325
NIH Device Record Key585a2025-ee4b-43a7-83fe-a546f1fa78d2
Commercial Distribution StatusIn Commercial Distribution
Brand NameTCR Multi
Version Model Number756224
Catalog Number756224
Company DUNS480467422
Company NameCandulor AG
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 Usefalse
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
GS107630813462325 [Primary]
HIBCCE1997562241 [Previous]

FDA Product Code

ELMDenture, plastic, teeth

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-28
Device Publish Date2025-05-20

On-Brand Devices [TCR Multi]

E1997562241TCR Multi D2 98.5-20MM
E1997562231TCR Multi C2 98.5-20MM
E1997562221TCR Multi B3 98.5-20MM
E1997562211TCR Multi B1 98.5-20MM
E1997562201TCR Multi A3.5 98.5-20MM
E1997562191TCR Multi A3 98.5-20MM
E1997562181TCR Multi A2 98.5-20MM
E1997562171TCR Multi A1 98.5-20MM
E1997562161TCR Multi BL3 98.5-20MM
07630813462325TCR Multi D2 98.5-20MM
07630813462318TCR Multi C2 98.5-20MM
07630813462288TCR Multi A3.5 98.5-20MM
07630813462257TCR Multi A1 98.5-20MM

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.