Bosworth SuperEBA
15 g Pwd & 6.5 ml Liq Cement Combo Kit, Fast & Reg. Set
3manufacturers in China registered for this device type
9catalogue numbers in this listing
4510(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 | Harry J. Bosworth Co., United States |
|---|---|
| FDA product code | EMA |
| Device type | Cement, Dental |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3275 |
| 510(k) | K983752 |
| Record published | 2016-09-15 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep away from moisture; Special storage condition: Keep out of direct sunlight |
| Sizes | Weight 15 g; total volume 1 Fluid Ounce; total volume 6.5 ml |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0921009 | Weight 15 g | In distribution |
| 0921007 | In distribution | |
| 0921007F | In distribution | |
| 0921012 | 2 oz | In distribution |
| 0921008 | Weight 15 g | In distribution |
| 0921013 | 2 oz | In distribution |
| 0921014 | Total Volume 1 Fluid Ounce | In distribution |
| 0921007R | In distribution | |
| 0921010 | Total Volume 6.5 ml | 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 |
|---|---|
| K103585 | 2011-03-04 |
| K983752 | 1998-12-10 |
| K981618 | 1998-07-28 |
| K874500 | 1988-02-18 |
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.