Identity
- Trade Name
- Opalescence Boost EUDAMED
- Device Name
- Opalescence Boost EUDAMED
- Model / Reference
- 4750-CE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00883205045065 EUDAMED
- Basic UDI-DI
- 0883205-REF4750-CENA EUDAMED
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- Intended for professional dental use to whiten and lighten discolored vital and non-vital teeth through the application of hydrogen peroxide-based tooth whitening gel. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Opalescence Boost by Ultradent Products, Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0883205-REF4750-CENA | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ultradent Products, Inc.
- EUDAMED SRN
- US-PR-000029822
Sources (1)
- EUDAMED 97c8b15d-1d26-4084-b098-bd624533ea39 61 fields · synced Jun 18, 2026