Freegenol™
FREEGENOL™ Standard Package (55g base, 20g catalyst, & mixing pad)
3manufacturers in China registered for this device type
1catalogue number
30510(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 | GC America Inc., United States |
|---|---|
| FDA product code | EMA |
| Device type | Cement, Dental |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3275 |
| Establishment | Contract manufacturer, Remanufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K842994 |
| Record published | 2016-08-01 |
| Record revised | 2026-01-21 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 39 to 77 °F; Storage environment temperature 4 to 25 °C |
| Packaging | Carton of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 136501 | 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 |
|---|---|
| K254109 | 2026-05-18 |
| K250953 | 2025-09-19 |
| K200798 | 2020-11-24 |
| K193484 | 2020-07-02 |
| K182854 | 2019-07-11 |
| K172382 | 2018-04-02 |
| K153231 | 2016-07-06 |
| K120243 | 2012-06-27 |
| K101420 | 2010-09-17 |
| K091106 | 2009-06-17 |
| K073283 | 2008-02-20 |
| K070840 | 2007-05-15 |
| K070319 | 2007-02-26 |
| K061535 | 2006-07-14 |
| K051427 | 2005-08-22 |
| K023727 | 2003-01-16 |
| K021038 | 2002-05-03 |
| K020117 | 2002-02-28 |
| K013198 | 2001-10-29 |
| K001823 | 2000-08-16 |
| K001730 | 2000-07-17 |
| K984505 | 1999-02-04 |
| K981370 | 1998-06-01 |
| K980695 | 1998-04-13 |
| K980682 | 1998-04-03 |
| K961448 | 1996-07-08 |
| K961584 | 1996-05-24 |
| K951555 | 1995-05-23 |
| K946100 | 1995-01-20 |
| K935521 | 1994-01-06 |
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.