AZ Primer
Catalogue number 3232, listed by Shofu Dental Corp., United States, under Cement, Dental. 3 manufacturers in China are registered for this product code.
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) | K080517 |
| Record published | 2016-09-26 |
| 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 |
|---|---|---|
| 3232 | 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.