Identity
- Trade Name
- SR Orthotyp DCL Juego de 8 IN2 D2 EUDAMEDResin Teeth / DCL / PE FDA UDI
- Generic Name
- Resin artificial teeth FDA UDI
- Device Name
- Ivostar / Gnathostar, Ivocryl, Resin Teeth / DCL / PE, Resin Teeth S PE / S DCL, SR Phonares II EUDAMEDSR Orthotyp DCL Set of 8 LN2 D2 FDA UDI
- Model / Reference
- 565696 EUDAMEDFDA UDI
- Description
- SR Orthotyp DCL Set of 8 LN2 D2 FDA UDI
Identifiers
- Catalog Number
- 565696 FDA UDI
- Primary DI / UDI-DI
- 07615208395785 EUDAMEDFDA UDI
- Basic UDI-DI
- 76152082APROS004VZ 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
- Liechtenstein 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
SR Orthotyp DCL Juego de 8 IN2 D2 by Ivoclar Vivadent AG — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 76152082APROS004VZ | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Ivoclar Vivadent AG
- EUDAMED SRN
- LI-MF-000000522
Sources (2)
- EUDAMED 1a22603f-32c0-4225-b441-8fdee15f6a32 61 fields · synced Oct 6, 2026
- FDA UDI bbb7ff70-f932-46ae-80bb-ee61377841eb 34 fields · synced May 25, 2026