Riva LC
Riva LC A3 PWD REF 15G
3manufacturers in China registered for this device type
59catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Shandong (2), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Huge Dental Material Corporation | Rizhao | Shandong | Manufacturer | 17 |
| Rizhao Huge Biomaterials Company, Ltd. | Rizhao | Shandong | Manufacturer | 7 |
| Shenzhen Upcera Dental Technology Co., Ltd. | Shenzhen | Guangdong | Private-label distributor | 6 |
Record
| Listed by | SDI Ltd., Australia |
|---|---|
| FDA product code | EMA |
| Device type | Cement, Dental |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3275 |
| Establishment | Manufacturer |
| 510(k) | K050870 |
| Record published | 2016-10-10 |
| Record revised | 2025-01-10 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Handling environment atmospheric pressure 5 to 25 °C |
| Distribution end date | 2025-01-09 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| RIVA LC A3.5 PWD REF 15G | In distribution | ||
| 8700014 | In distribution | ||
| RIVA LC A3.5 P/L KT | In distribution | ||
| RIVA LC B2 PWD REF 15G | In distribution | ||
| RIVA LC C2 P/L KT | In distribution | ||
| 8700503 | In distribution | ||
| 8700501 | In distribution | ||
| RIVA LC C2 PWD REF 15G | In distribution | ||
| 8700004 | In distribution | ||
| 8700900 | In distribution | ||
| RIVA LC STARTER KT A1 | 20 | In distribution | |
| 8700003 | In distribution | ||
| RIVA LC B PWD REF 15G | In distribution | ||
| 8700001 | In distribution | ||
| 8700002 | In distribution | ||
| RIVA LC A4 P/L KT | In distribution | ||
| RIVA LC A1 PWD REF 15G | In distribution | ||
| RIVA LC C4 PWD REF 15G | In distribution | ||
| 8730006 | In distribution | ||
| 8730001 | In distribution | ||
| 8700010 | In distribution | ||
| 8730003 | In distribution | ||
| 8730002 | In distribution | ||
| 8700005 | In distribution | ||
| 8700012 | In distribution | ||
| 8700502 | In distribution | ||
| 8700103 | In distribution | ||
| RIVA LC B2 P/L KT | In distribution | ||
| 8730004 | In distribution | ||
| 8700102 | In distribution | ||
| 8700008 | In distribution | ||
| RIVA LC STARTER KT A2 | 20 | In distribution | |
| 8700007 | In distribution | ||
| 8700016 | In distribution | ||
| 8710000 | In distribution | ||
| RIVA LC B3 PWD REF 15G | In distribution | ||
| RIVA LC A2 PWD REF 15G | Withdrawn | ||
| RIVA LC HV A3 50 CAP | 50 | Withdrawn | |
| RIVA LC C4 50 CAP | 50 | Withdrawn | |
| RIVA LC HV A2 50 CAP | 50 | Withdrawn | |
| RIVA LC B2 50 CAP | 50 | Withdrawn | |
| RIVA LC A3 P/L KT | Withdrawn | ||
| RIVA LC B 50 CAP | 50 | Withdrawn | |
| RIVA LC A2 50 CAP | 50 | Withdrawn | |
| RIVA LC C2 50 CAP | 50 | Withdrawn | |
| RIVA LC A1 50 CAP | 50 | Withdrawn | |
| RIVA LC A3 PWD REF 15G | Withdrawn | ||
| RIVA LC A2 P/L KT | Withdrawn | ||
| RIVA LC A4 50 CAP | 50 | Withdrawn | |
| RIVA LC LQD REF | Withdrawn | ||
| RIVA LC HV A1 50 CAP | 50 | Withdrawn | |
| RIVA LC A1 P/L KT | Withdrawn | ||
| RIVA LC HV A3.5 50 CAP | 50 | Withdrawn | |
| RIVA LC CAP ASSTD KT | 50 | Withdrawn | |
| RIVA LC A3.5 50 CAP | 50 | Withdrawn | |
| RIVA LC B4 50 CAP | 50 | Withdrawn | |
| RIVA LC HV B1 50 CAP | 50 | Withdrawn | |
| RIVA LC B3 50 CAP | 50 | Withdrawn | |
| RIVA LC A3 50 CAP | 50 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| GC Fuji II LC® | GC America Inc. | 78 |
| Equia® | GC America Inc. | 73 |
| Riva SC | SDI Ltd. | 72 |
| Denture Base | American Tooth Industries | 61 |
| GC Fuji IX GP® | GC America Inc. | 58 |
| GlasIonomer FX-LC | Shofu Dental Corp. | 45 |
| Henry Schein | Henry Schein, Inc. | 35 |
| Esthet-X®flow Liquid Micro Hybrid | Dentsply LLC | 24 |
| Photac™ Fil Quick Aplicap™ | 3M Deutschland GmbH | 24 |
| Ketac™ Fil Plus Aplicap™ | 3M Deutschland GmbH | 23 |
| Ultra-Bond® | DEN-MAT Holdings, LLC | 23 |
| TPH®3 flow Liquid Micro Hybrid | Dentsply LLC | 22 |
Showing 12 of 780. All products under Cement, Dental
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K214118 | 2022-08-30 |
| K073043 | 2007-12-14 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.