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Empress Direct Ref. 10x0.2g A3 Dentin
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 627260AN
Identity
- Trade Name
- Empress Direct Ref. 10x0.2g A3 Dentin EUDAMEDIPS Empress Direct FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- IPS Empress Direct EUDAMEDEmpress Direct Ref. 10x0.2g A3 Dentin FDA UDI
- Model / Reference
- 627260AN EUDAMEDFDA UDI
- Description
- Empress Direct Ref. 10x0.2g A3 Dentin FDA UDI
Identifiers
- Catalog Number
- 627260AN FDA UDI
- Primary DI / UDI-DI
- 07615208298291 EUDAMEDFDA UDI
- Basic UDI-DI
- 76152082AFILL009JS EUDAMED
- Unit of Use DI
- 07615208472189 EUDAMED
- FDA Product Code
- EBF FDA UDI
- EMDN Code
- Q01010103 DENTAL RESTORATIVE COMPOSITES EUDAMED
- GMDN Term
- Dental composite resin FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3690 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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental composite resin
Empress Direct Ref. 10x0.2g A3 Dentin by Ivoclar Vivadent AG — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 76152082AFILL009JS | 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 55d257a8-52f6-4c99-9418-9c05886219bc 61 fields · synced Jul 9, 2026
- FDA UDI ee17e1e4-c2f2-4ba7-b7fd-ecd54bf1240f 34 fields · synced May 30, 2026