Identity
- Trade Name
- Physioset TCR Set of 6 U232+ B4 EUDAMEDCandulor TCR FDA UDI
- Generic Name
- Resin artificial teeth FDA UDI
- Device Name
- Physioset TCR, Bonartic TCR, PhysioSelect TCR, BonSelect TCR, Preference, Bonartic II NFC plus, PhysioStar NFC plus, Condyloform II NFC plus EUDAMEDPhysioset TCR Set of 6 U232+ B4 FDA UDI
- Model / Reference
- 600431 EUDAMEDFDA UDI
- Description
- Physioset TCR Set of 6 U232+ B4 FDA UDI
Identifiers
- Catalog Number
- 600431 FDA UDI
- Primary DI / UDI-DI
- 07630813484495 EUDAMEDFDA UDI
- Basic UDI-DI
- 763081342APROS002VE EUDAMED
- FDA Product Code
- ELM FDA UDI
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Resin artificial teeth FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3590 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Resin artificial teeth
Candulor TCR by Candulor AG — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Resin artificial teeth.
- Resin Teeth / DCL / PE — IVOCLAR VIVADENT AKTIENGESELLSCHAFT · Class II
- Portrait® IPN® Anteriors — Dentsply International · Class II
- artegral life — Merz Dental GmbH · Class II
- Mondial 8i, D4 / M, CE — Kulzer, Inc. · Class II
- Monarch — Wright Health Group , Ltd. · Class II
- Ref-Line — POLIDENT d.o.o. · Class II
- artegral life — Merz Dental GmbH · Class II
- Resin Teeth DCL PE — IVOCLAR VIVADENT AKTIENGESELLSCHAFT · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Candulor AG
Sources (2)
- FDA UDI 0d3a4161-8ce2-4964-8d3c-27b620f97bda 34 fields · synced Sep 17, 2026
- EUDAMED a0848ec5-ac22-4f7d-8f8e-134ff0645dc9 61 fields · synced Sep 17, 2026