Identity
- Trade Name
- RIVA PROTECT FDA UDI
- Generic Name
- Glass ionomer dental cement FDA UDI
- Model / Reference
- RIVA PROTECT PINK 50 CAP FAST FDA UDI
Identifiers
- Catalog Number
- 8685000 FDA UDI
- Primary DI / UDI-DI
- DO3686850001 FDA UDI
- 510(k) Number
- K050871 FDA UDI
- FDA Product Code
- EBC FDA UDI
- GMDN Term
- Glass ionomer dental cement FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3765 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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 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
Riva Protect by Sdi , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Sdi , Ltd.
Sources (1)
- FDA UDI 0094c355-fbab-46e7-a740-1aed6c1edb70 37 fields · synced May 30, 2026