FDA.reportPublic FDA data

TCR Multi

Primary DI
07630813462639
Brand
TCR Multi
Company
Candulor AG
Model
771192
Catalog number
771192
Device description
TCR Multi A4 98.5-20MM
Published
2026-07-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
ELMDenture, plastic, teeth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELMDenture, Plastic, TeethDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630813462639PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630813462639076308134626397630813462639

GMDN Terms#

Term, Definition table
TermDefinition
Resin artificial teethPrefabricated teeth made of polymer-based material for mounting on dentures. Teeth are normally delivered as sets of front teeth, upper or lower jaw, or sets of premolars and molars, upper or lower jaw, in various sizes, shapes and colours.

Regulatory Flags#

DUNS number
480467422
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630813462523XPLEX Base7712067712062026-07-28
07630813462646TCR Multi7711937711932026-07-28
07630813462653TCR Multi7711967711962026-07-28
07630813462660TCR Multi7711977711972026-07-28
07630813462677TCR Multi7711987711982026-07-28
07630813462165TCR Mono7561987561982025-05-20
07630813462202TCR Mono7562027562022025-05-20
07630813462226TCR Mono7562047562042025-05-20
07630813462233TCR Mono7562057562052025-05-20
07630813462240TCR Multi7562167562162025-05-20
07630813462264TCR Multi7562187562182025-05-20
07630813462271TCR Multi7562197562192025-05-20
07630813462295TCR Multi7562217562212025-05-20
07630813462301TCR Multi7562227562222025-05-20
07630813462158TCR Mono7561977561972025-05-20
07630813462172TCR Mono7561997561992025-05-20
07630813462189TCR Mono7562007562002025-05-20
07630813462196TCR Mono7562017562012025-05-20
07630813462219TCR Mono7562037562032025-05-20
07630813462257TCR Multi7562177562172025-05-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630813462646TCR MultiCandulor AGELM2026-07-28
07630813462653TCR MultiCandulor AGELM2026-07-28
07630813462660TCR MultiCandulor AGELM2026-07-28
07630813462677TCR MultiCandulor AGELM2026-07-28
07615208592634Ivotion DentIVOCLAR VIVADENT AKTIENGESELLSCHAFTELM2026-07-09
07615208592689Ivotion DentIVOCLAR VIVADENT AKTIENGESELLSCHAFTELM2026-07-09
07615208592696Ivotion DentIVOCLAR VIVADENT AKTIENGESELLSCHAFTELM2026-07-09
07615208592702Ivotion DentIVOCLAR VIVADENT AKTIENGESELLSCHAFTELM2026-07-09
07615208592719Ivotion DentIVOCLAR VIVADENT AKTIENGESELLSCHAFTELM2026-07-09
E235DPCS0DentaprintSHOFU DENTAL CORPORATIONELM2026-06-23
E235DPMS0DentaprintSHOFU DENTAL CORPORATIONELM2026-06-23
E235DPOMS0DentaprintSHOFU DENTAL CORPORATIONELM2026-06-23
E235DPSGS0DentaprintSHOFU DENTAL CORPORATIONELM2026-06-23
E235DPTIS0DentaprintSHOFU DENTAL CORPORATIONELM2026-06-23
EGEB290040TRIBOS 501 C Composite teeth SLA-UJ-3,5Gebdi Dental-Products GmbHELM2026-06-03
EPOLCL01A2CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01A3CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01A4CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01A9CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01B1CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01B2CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01B3CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01B4CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01C1CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01C2CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01C3CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01C4CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01D2CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01D3CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01D4CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10