Data / Medical devices / Coating, Filling Material, Resin
Coating, Filling Material, Resin (EBD): 30 FDA-registered makers in 7 countries
30 establishments in 7 countries are registered with the FDA to make Coating, Filling Material, Resin (product code EBD, Class 2, 21 CFR 872.3310). 21 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 52 510(k) clearances under this code, the latest on April 6, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- EBD
- Device class
- 2
- Regulation
- 872.3310
- Medical specialty
- Dental
Makers by country
| Country | Makers |
|---|---|
| United States | 11 |
| Germany | 9 |
| Japan | 6 |
| South Korea | 1 |
| China | 1 |
| Liechtenstein | 1 |
| India | 1 |
Makers of Coating, Filling Material, Resin
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| GC America Inc. | Alsip, IL, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 3 | March 6, 2014 | 0 | 0 | 0 | api.fda.gov |
| Scientific Pharmaceuticals, Inc. | Pomona, CA, United States | Contract manufacturer, Manufacturer | 3 | March 25, 1985 | 0 | 0 | 0 | api.fda.gov |
| DMG Chemisch Pharmazeutische Fabrik GMBH | Hamburg, Germany | Manufacturer | 2 | October 12, 2001 | 0 | 0 | 0 | api.fda.gov |
| Reliance Orthodontic Products, Inc. | Itasca, IL, United States | Repackager or relabeler, Specification developer | 2 | February 8, 2008 | 0 | 0 | 0 | api.fda.gov |
| Vita Zahnfabrik H. Rauter GMBH & Co. KG. | BAD SACKINGEN Baden-Wurttemberg, Germany | Complaint file establishment, Manufacturer, Repackager or relabeler | 2 | November 22, 2021 | 0 | 0 | 0 | api.fda.gov |
| Bisco, Inc. | Schaumburg, IL, United States | Contract manufacturer, Manufacturer | 1 | April 28, 2003 | 0 | 0 | 0 | api.fda.gov |
| Bredent GMBH & Co.kg | SENDEN Bavaria, Germany | Manufacturer | 1 | December 12, 2024 | 0 | 0 | 0 | api.fda.gov |
| Deltamed GMBH | FRIEDBERG Hesse, Germany | Manufacturer | 1 | February 10, 1998 | 0 | 0 | 0 | api.fda.gov |
| Dreve Dentamid GMBH | UNNA North Rhine-Westphalia, Germany | Manufacturer | 1 | April 5, 2018 | 0 | 0 | 0 | api.fda.gov |
| GC Asahi Corporation | Aichi, Japan | Manufacturer | 1 | March 6, 2014 | 0 | 0 | 0 | api.fda.gov |
| GC Corp. | ITABASHI-KU Tokyo, Japan | Manufacturer | 1 | October 20, 2005 | 0 | 0 | 0 | api.fda.gov |
| GC Corporation-Fuji Oyama Factory | SUNTO-GUN, Shizuoka-Ken, Japan | Manufacturer | 1 | October 20, 2005 | 0 | 0 | 0 | api.fda.gov |
| GC Dental Products Corp. | KASUGAI-SHI Aichi, Japan | Manufacturer | 1 | March 6, 2014 | 0 | 0 | 0 | api.fda.gov |
| Id Korea Co., Ltd. | Dong-gu Gwangju, South Korea | Manufacturer | 1 | June 4, 2025 | 0 | 0 | 0 | api.fda.gov |
| Pac-Dent Inc. | Brea, CA, United States | Manufacturer | 1 | March 27, 2023 | 0 | 0 | 0 | api.fda.gov |
| Parkell, Inc. | Edgewood, NY, United States | Manufacturer | 1 | April 9, 2004 | 0 | 0 | 0 | api.fda.gov |
| Shofu Inc. | FUKUINE, HIGASHIYAMA-KU Kyoto, Japan | Manufacturer | 1 | August 16, 2017 | 0 | 0 | 0 | api.fda.gov |
| Solventum Germany GmbH | SEEFELD Bavaria, Germany | Manufacturer | 1 | August 19, 1985 | 0 | 0 | 0 | api.fda.gov |
| Voco GMBH | CUXHAVEN Lower Saxony, Germany | Manufacturer | 1 | October 24, 2008 | 0 | 0 | 0 | api.fda.gov |
| Yamahachi Dental MFG. Co. | Gamagori City Aichi, Japan | Complaint file establishment, Manufacturer | 1 | April 6, 2026 | 0 | 0 | 0 | api.fda.gov |
| Yamahachi Dental Material (Changshu) Co., Ltd. | Changshu city Jiangsu, China | Manufacturer | 1 | April 6, 2026 | 0 | 0 | 0 | api.fda.gov |
| Den-Mat Holdings, LLC | Lompoc, CA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentsply LLC | Milford, DE, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentsply LLC | York, PA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| George Taub Products & Fusion Co., Inc. | Jersey City, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ivoclar Vivadent AG | Schaan, Liechtenstein | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kulzer GMBH | HANAU Hesse, Germany | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kulzer GMBH | WEHRHEIM Hesse, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| M/S Leixir Resources Pvt. Ltd | GURUGRAM Haryana, India | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pulpdent Corporation | Watertown, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 6, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.