GC Fuji IX GP®
GC Fuji IX GP® FAST Capsule (48) Assorted Starter (10 each of A2, A3, A3.5, 9 each of B2 & B3, Capsule Applier, Cavity Conditioner, and Fuji COAT LC)
3manufacturers in China registered for this device type
58catalogue numbers in this listing
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) | K961448 |
| Record published | 2016-08-01 |
| Record revised | 2026-01-21 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 4 to 25 °C; Storage environment temperature 39 to 77 °F |
| Packaging | Carton of 5 |
| Sizes | Weight 15 g; total volume 6.4 ml |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 425085 | 48 | In distribution | |
| 425041 | 48 | In distribution | |
| 425062 | 48 | In distribution | |
| 425043 | 48 | In distribution | |
| 000152 | In distribution | ||
| 439901 | In distribution | ||
| 425065 | 48 | In distribution | |
| 425042 | 48 | In distribution | |
| 425063 | 48 | In distribution | |
| 425082 | 48 | In distribution | |
| 425045 | 48 | In distribution | |
| 000152 | In distribution | ||
| 425070 | 48 | In distribution | |
| 425081 | 48 | In distribution | |
| 425085 | 48 | In distribution | |
| 425040 | 48 | In distribution | |
| 000158 | Weight 15 g | In distribution | |
| 425041 | 48 | In distribution | |
| 425080 | 48 | In distribution | |
| 425084 | 48 | In distribution | |
| 000164 | Total Volume 6.4 ml | In distribution | |
| 425050 | 48 | In distribution | |
| 425060 | 48 | In distribution | |
| 425064 | 48 | In distribution | |
| 425066 | 48 | In distribution | |
| 439901 | In distribution | ||
| 425044 | 48 | In distribution | |
| 425080 | 48 | In distribution | |
| 425061 | 48 | In distribution | |
| 425083 | 48 | In distribution | |
| 425061 | 48 | In distribution | |
| 425083 | 48 | In distribution | |
| 425043 | 48 | In distribution | |
| 425050 | 48 | In distribution | |
| 425042 | 48 | In distribution | |
| 425082 | 48 | In distribution | |
| 425060 | 48 | In distribution | |
| 425084 | 48 | In distribution | |
| 425065 | 48 | In distribution | |
| 000164 | Total Volume 6.4 ml | In distribution | |
| 425040 | 48 | In distribution | |
| 425047 | 48 | In distribution | |
| 425048 | 48 | In distribution | |
| 425045 | 48 | In distribution | |
| 425090 | 48 | In distribution | |
| 000158 | Weight 15 g | In distribution | |
| 425047 | 48 | In distribution | |
| 425064 | 48 | In distribution | |
| 425063 | 48 | In distribution | |
| 425048 | 48 | In distribution | |
| 425090 | 48 | In distribution | |
| 425070 | 48 | In distribution | |
| 425081 | 48 | In distribution | |
| 425044 | 48 | In distribution | |
| 425046 | 48 | In distribution | |
| 425046 | 48 | In distribution | |
| 425062 | 48 | In distribution | |
| 425066 | 48 | 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 |
| 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 |
| TPH®3 flow Liquid Micro Hybrid | Dentsply LLC | 22 |
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.