TCR Mono 756200

GUDID 07630813462189

TCR Mono A3 98.5-20MM

Candulor AG

Resin artificial teeth
Primary Device ID07630813462189
NIH Device Record Keya7fefd3b-b681-42e2-b7b8-e4f198ec0318
Commercial Distribution StatusIn Commercial Distribution
Brand NameTCR Mono
Version Model Number756200
Catalog Number756200
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
GS107630813462189 [Primary]
HIBCCE1997562001 [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 Mono]

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E1997562041TCR Mono C2 98.5-20MM
E1997562031TCR Mono B3 98.5-20MM
E1997562021TCR Mono B1 98.5-20MM
E1997562011TCR Mono A3.5 98.5-20MM
E1997562001TCR Mono A3 98.5-20MM
E1997561991TCR Mono A2 98.5-20MM
E1997561981TCR Mono A1 98.5-20MM
E1997561971TCR Mono BL3 98.5-20MM
07630813462219TCR Mono B3 98.5-20MM
07630813462196TCR Mono A3.5 98.5-20MM
07630813462189TCR Mono A3 98.5-20MM
07630813462172TCR Mono A2 98.5-20MM
07630813462158TCR Mono BL3 98.5-20MM

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