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Empress Direct Refill 1x3g A3 Dentin
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 627222AN
Identity
- Trade Name
- Empress Direct Refill 1x3g A3 Dentin EUDAMEDIPS Empress Direct FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- IPS Empress Direct EUDAMEDEmpress Direct Refill 1x3g A3 Dentin FDA UDI
- Model / Reference
- 627222AN EUDAMEDFDA UDI
- Description
- Empress Direct Refill 1x3g A3 Dentin FDA UDI
Identifiers
- Catalog Number
- 627222AN FDA UDI
- Primary DI / UDI-DI
- 07615208009088 EUDAMEDFDA UDI
- Basic UDI-DI
- 76152082AFILL009JS 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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental composite resin
Empress Direct Refill 1x3g A3 Dentin by Ivoclar Vivadent AG — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental composite resin.
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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 aa792ce0-ec90-4f89-8615-8da3921e9453 61 fields · synced Jun 19, 2026
- FDA UDI 1b87ce5b-a6c6-4998-b8dd-349d97e828d9 34 fields · synced May 30, 2026