Identity
- Trade Name
- IPS Classic V Dentin 20 g D4 EUDAMEDIPS Classic FDA UDI
- Generic Name
- Dental appliance fabrication material, ceramic FDA UDI
- Device Name
- IPS Classic EUDAMEDIPS Classic V Dentin 20 g D4 FDA UDI
- Model / Reference
- 531662 EUDAMEDFDA UDI
- Description
- IPS Classic V Dentin 20 g D4 FDA UDI
Identifiers
- Catalog Number
- 531662 FDA UDI
- Primary DI / UDI-DI
- 07615208420296 EUDAMEDFDA UDI
- Basic UDI-DI
- 76152082ACERA003EU EUDAMED
- FDA Product Code
- EIH FDA UDI
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Dental appliance fabrication material, ceramic FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.6660 FDA UDI
- Market of Registration
- Liechtenstein EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
Yes
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
IPS Classic V Dentin 20 g D4 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 | 76152082ACERA003EU | 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 196ce413-b015-4b56-ae21-aec60935d60e 61 fields · synced Oct 6, 2026
- FDA UDI 615507c7-18f2-4faa-9627-c9376a0f9153 34 fields · synced May 30, 2026