Activa BioACTIVE-RESTORATIVE
ACTIVA REST START KIT A3.5 SHADE 1-syringe, 20 tips & Dispenser
3manufacturers in China registered for this device type
12catalogue numbers in this listing
14510(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 | Pulpdent Corporation, United States |
|---|---|
| FDA product code | EMA |
| Device type | Cement, Dental |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3275 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K130223 |
| Record published | 2019-11-22 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VRA35 | In distribution | |
| VR1A3 | In distribution | |
| VR2A1 | In distribution | |
| VR1A1 | In distribution | |
| VR2A2 | In distribution | |
| VR1A35 | In distribution | |
| VRA3 | In distribution | |
| VRA1 | In distribution | |
| VR1A2 | In distribution | |
| VRA2 | In distribution | |
| VR2A3 | In distribution | |
| VR2A35 | In distribution |
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 |
| 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 |
Showing 12 of 780. All products under Cement, Dental
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K130223 | 2013-03-29 |
| K123265 | 2012-12-07 |
| K040236 | 2004-04-20 |
| K020481 | 2002-04-17 |
| K974014 | 1997-12-17 |
| K972445 | 1997-10-02 |
| K962747 | 1996-09-30 |
| K962383 | 1996-09-03 |
| K955017 | 1995-12-01 |
| K953301 | 1995-08-25 |
| K953272 | 1995-08-25 |
| K952960 | 1995-07-19 |
| K951270 | 1995-05-31 |
| K946137 | 1995-01-26 |
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.