Identity
- Trade Name
- Opalustre EUDAMEDFDA UDI
- Generic Name
- Professional dental abrasive material FDA UDIDentifrice FDA UDI
- Device Name
- Opalustre EUDAMEDOpalustre Refill FDA UDIOpalustre 2 Pack FDA UDI
- Model / Reference
- 5554 EUDAMEDFDA UDI555 FDA UDI
- Description
- Opalustre Refill FDA UDIOpalustre 2 Pack FDA UDI
Identifiers
- Catalog Number
- 555 FDA UDI5554 FDA UDI
- Primary DI / UDI-DI
- 00883205104328 EUDAMEDFDA UDI00883205103567 FDA UDI
- Basic UDI-DI
- 0883205-REF55547J EUDAMED
- FDA Product Code
- EJR FDA UDI
- EMDN Code
- Q01010403 DENTAL ABRASIVE AND POLISHING MATERIALS EUDAMED
- GMDN Term
- Professional dental abrasive material FDA UDIDentifrice FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.6030 FDA UDI
- Medical Purpose
- The removal and treatment of superficial enamel discolorations, decalcifications, and fluorosis-related defects through chemical and mechanical microabrasion of the tooth enamel surface. EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDIFDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Professional dental abrasive material
Opalustre by Ultradent Products, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Ultradent Products, Inc.
Sources (3)
- FDA UDI 1774ac8b-354d-4014-a03b-c4c2fd7275b9 36 fields · synced Jul 19, 2026
- FDA UDI 8fddbe21-2606-4fcd-a229-131a9a334663 36 fields · synced May 30, 2026
- EUDAMED c6650821-22c2-460e-8a5d-45d2128d1de4 61 fields · synced Jul 19, 2026