Riva SC
Riva SC T-A2 P/L KT REG 15G
3manufacturers in China registered for this device type
72catalogue 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) | K030516 |
| Record published | 2016-09-30 |
| 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 SC T-A3.5 P/L KT REG 15G | In distribution | ||
| 8600007 | In distribution | ||
| 8605008 | In distribution | ||
| 8600013 | In distribution | ||
| 8600008 | In distribution | ||
| 8605004 | In distribution | ||
| 8605002 | In distribution | ||
| 8630001 | In distribution | ||
| 8610000 | In distribution | ||
| RIVA SC A2 PWD REF 15G | In distribution | ||
| 8630002 | In distribution | ||
| 8600011 | In distribution | ||
| 8630003 | In distribution | ||
| 8610502 | In distribution | ||
| RIVA SC STARTER REG KT A1 | 20 | In distribution | |
| 8610103 | In distribution | ||
| RIVA SC B2 P/L KT | In distribution | ||
| 8600005 | In distribution | ||
| 8600002 | In distribution | ||
| 8630004 | In distribution | ||
| 8605003 | In distribution | ||
| 8600001 | In distribution | ||
| 8600004 | In distribution | ||
| 8605005 | In distribution | ||
| 8610501 | In distribution | ||
| 8610503 | In distribution | ||
| 8605007 | In distribution | ||
| 8605001 | In distribution | ||
| RIVA SC STARTER FAST KT A2 | 20 | In distribution | |
| 8620000 | In distribution | ||
| RIVA SC B3 P/L KT | In distribution | ||
| RIVA SC STARTER REG KT A2 | 20 | In distribution | |
| 8610521 | In distribution | ||
| RIVA SC STARTER FAST KT A1 | 20 | In distribution | |
| 8610522 | In distribution | ||
| RIVA SC A4 PWD REF 15G | In distribution | ||
| RIVA SC B3 PWD REF 15G | In distribution | ||
| 8610504 | In distribution | ||
| RIVA SC A1 PWD REF 15G | In distribution | ||
| 8600003 | In distribution | ||
| 8600012 | In distribution | ||
| RIVA SC A4 P/L KT | In distribution | ||
| RIVA SC B3 REG 50 CAP | 50 | Withdrawn | |
| RIVA SC CAP FAST ASSTD KT | Withdrawn | ||
| RIVA SC A1 FAST 50 CAP | 50 | Withdrawn | |
| RIVA SC A3.5 REG 50 CAP | 50 | Withdrawn | |
| RIVA SC B2 FAST 50 CAP | 50 | Withdrawn | |
| RIVA SC HV A2 50 CAP | 50 | Withdrawn | |
| RIVA SC A2 REG 50 CAP | 50 | Withdrawn | |
| RIVA SC A1 P/L KT | Withdrawn | ||
| RIVA SC A1 REG 50 CAP | 50 | Withdrawn | |
| RIVA SC HV A3.5 50 CAP | 50 | Withdrawn | |
| RIVA SC A2 FAST 50 CAP | 50 | Withdrawn | |
| RIVA SC A3 REG 50 CAP | 50 | Withdrawn | |
| RIVA SC A2 P/L KT | Withdrawn | ||
| RIVA SC CAP REG ASSTD KT | 50 | Withdrawn | |
| RIVA SC A3 PWD REF 15G | Withdrawn | ||
| RIVA SC B3 FAST 50 CAP | 50 | Withdrawn | |
| RIVA SC HV A3 50 CAP | 50 | Withdrawn | |
| RIVA SC T-A2 P/L KT REG 15G | Withdrawn | ||
| RIVA SC T-A3.5 FAST 50 CAP | 50 | Withdrawn | |
| RIVA SC A4 REG 50 CAP | 50 | Withdrawn | |
| RIVA SC T-A3 FAST 50 CAP | 50 | Withdrawn | |
| RIVA SC A3 P/L KT | Withdrawn | ||
| RIVA SC T-A3 P/L KT REG 15G | Withdrawn | ||
| RIVA SC A4 FAST 50 CAP | 50 | Withdrawn | |
| RIVA SC A3.5 P/L KT | Withdrawn | ||
| RIVA SC T-A2 FAST 50 CAP | 50 | Withdrawn | |
| RIVA SC B2 REG 50 CAP | 50 | Withdrawn | |
| RIVA SC A3 FAST 50 CAP | 50 | Withdrawn | |
| RIVA SC HV A1 50 CAP | 50 | Withdrawn | |
| RIVA SC A3.5 FAST 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 |
| Denture Base | American Tooth Industries | 61 |
| Riva LC | SDI Ltd. | 59 |
| 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.