Identity
- Trade Name
- RIVA LC FDA UDI
- Generic Name
- Glass ionomer dental cement FDA UDI
- Device Name
- RIVA LC CAP ASSTD KT FDA UDI
- Model / Reference
- 8710000 FDA UDI
- Description
- RIVA LC CAP ASSTD KT FDA UDI
Identifiers
- Catalog Number
- 8710000 FDA UDI
- Primary DI / UDI-DI
- 09336472018085 FDA UDI
- 510(k) Number
- K050870 FDA UDI
- FDA Product Code
- EMA FDA UDI
- GMDN Term
- Glass ionomer dental cement FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3275 FDA UDI
- Commercial Distribution
- 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
Yes
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: Glass ionomer dental cement
Riva Lc by Sdi , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K050870 also covers:
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 f109fea2-10e7-47f0-8b3d-ca695599a0b0 36 fields · synced May 30, 2026