HY-Bond Polycarboxylate Cement
HY-Bond Poly KIT
3manufacturers in China registered for this device type
1catalogue number
24510(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 | Shofu Dental Corp., United States |
|---|---|
| FDA product code | EMA |
| Device type | Cement, Dental |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3275 |
| Establishment | Repacker / relabeller |
| 510(k) | K002461 |
| Record published | 2016-09-23 |
| Record revised | 2018-07-06 (version 3) |
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 |
|---|---|---|
| 1160 | 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 |
|---|---|
| K252808 | 2025-12-09 |
| K252165 | 2025-10-28 |
| K251470 | 2025-07-11 |
| K233161 | 2023-09-28 |
| K222253 | 2022-09-22 |
| K120159 | 2012-06-18 |
| K112307 | 2012-03-28 |
| K111855 | 2011-11-17 |
| K111685 | 2011-09-02 |
| K080517 | 2008-06-11 |
| K031467 | 2003-07-17 |
| K002461 | 2000-09-26 |
| K982461 | 1998-08-24 |
| K971927 | 1997-06-30 |
| K945451 | 1995-02-27 |
| K940122 | 1994-05-02 |
| K863141 | 1986-08-26 |
| K862280 | 1986-06-23 |
| K861005 | 1986-04-25 |
| K850913 | 1985-04-10 |
| K841195 | 1984-05-14 |
| K841196 | 1984-05-11 |
| K810765 | 1981-06-12 |
| K810764 | 1981-06-12 |
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.