Data / Medical devices / Crown And Bridge, Temporary, Resin
Crown And Bridge, Temporary, Resin (EBG): 117 FDA-registered makers in 22 countries
117 establishments in 22 countries are registered with the FDA to make Crown And Bridge, Temporary, Resin (product code EBG, Class 2, 21 CFR 872.3770). 85 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 189 510(k) clearances under this code, the latest on April 17, 2026, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- EBG
- Device class
- 2
- Regulation
- 872.3770
- Medical specialty
- Dental
Makers by country
| Country | Makers |
|---|---|
| United States | 39 |
| Germany | 21 |
| China | 11 |
| South Korea | 7 |
| Italy | 7 |
| Japan | 6 |
| Brazil | 4 |
| Switzerland | 3 |
| Mexico | 3 |
| Spain | 2 |
| India | 2 |
| Israel | 2 |
| Liechtenstein | 1 |
| Australia | 1 |
| Austria | 1 |
| Greece | 1 |
| Taiwan | 1 |
| Belgium | 1 |
| Colombia | 1 |
| Slovenia | 1 |
| United Kingdom | 1 |
| Netherlands | 1 |
Makers of Crown And Bridge, Temporary, 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 | 7 | July 9, 2020 | 0 | 0 | 0 | api.fda.gov |
| DMG Chemisch Pharmazeutische Fabrik GMBH | Hamburg, Germany | Manufacturer | 4 | May 29, 2019 | 0 | 0 | 0 | api.fda.gov |
| GC Dental Products Corp. | KASUGAI-SHI Aichi, Japan | Manufacturer | 4 | September 5, 2014 | 0 | 0 | 0 | api.fda.gov |
| Ivoclar Vivadent AG | Schaan, Liechtenstein | Manufacturer, Specification developer | 4 | February 14, 2011 | 0 | 0 | 0 | api.fda.gov |
| Voco GMBH | CUXHAVEN Lower Saxony, Germany | Manufacturer | 4 | September 9, 2020 | 0 | 0 | 0 | api.fda.gov |
| Dentsply LLC | Milford, DE, United States | Contract manufacturer, Manufacturer, Specification developer | 3 | September 28, 2010 | 0 | 0 | 0 | api.fda.gov |
| Kerr Corporation | Orange, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 3 | February 22, 2002 | 0 | 0 | 0 | api.fda.gov |
| Lang Dental MFG. Co., Inc. | Wheeling, IL, United States | Complaint file establishment, Manufacturer | 3 | June 5, 2009 | 0 | 1 | 0 | api.fda.gov |
| Solventum Germany GmbH | SEEFELD Bavaria, Germany | Manufacturer | 3 | January 9, 2008 | 0 | 0 | 0 | api.fda.gov |
| anax dent GmbH | Stuttgart Baden-Wurttemberg, Germany | Manufacturer | 3 | December 16, 2010 | 0 | 0 | 0 | api.fda.gov |
| Advantage Dental Products, Inc. | Clarkston, MI, United States | Manufacturer, Repackager or relabeler | 2 | August 4, 2004 | 0 | 0 | 0 | api.fda.gov |
| Aidite (qinhuangdao) Technology Co., Ltd | Qinhuangdao City Hebei, China | Manufacturer | 2 | February 16, 2023 | 0 | 0 | 0 | api.fda.gov |
| Detax GMBH | ETTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 2 | October 27, 2020 | 0 | 0 | 0 | api.fda.gov |
| Diadent Group International | CHONGJU CITY Chungbuk, South Korea | Manufacturer | 2 | February 13, 2020 | 0 | 0 | 0 | api.fda.gov |
| Danville Materials Research Center | Anaheim, CA, United States | Manufacturer | 2 | September 11, 2019 | 0 | 0 | 0 | api.fda.gov |
| GC Corp. | ITABASHI-KU Tokyo, Japan | Complaint file establishment, Exporter to the US, Manufacturer | 2 | January 16, 2001 | 0 | 0 | 0 | api.fda.gov |
| Merz Dental GMBH | LUETJENBURG Schleswig-Holstein, Germany | Manufacturer | 2 | May 2, 2008 | 0 | 0 | 0 | api.fda.gov |
| Meta Biomed Co., Ltd. | Cheongju-si Chungbuk, South Korea | Manufacturer | 2 | July 3, 2019 | 0 | 0 | 0 | api.fda.gov |
| Myohealth Technologies, LLC | Portland, OR, United States | Manufacturer | 2 | November 3, 2020 | 0 | 0 | 0 | api.fda.gov |
| Parkell, Inc. | Edgewood, NY, United States | Manufacturer, Repackager or relabeler | 2 | May 21, 1999 | 0 | 0 | 0 | api.fda.gov |
| Prismatik Dentalcraft, Inc. | Irvine, CA, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 2 | November 3, 2020 | 0 | 0 | 0 | api.fda.gov |
| Pulpdent Corporation | Watertown, MA, United States | Manufacturer | 2 | June 8, 2012 | 0 | 0 | 0 | api.fda.gov |
| S & C Polymer GMBH | ELMSHORN Schleswig-Holstein, Germany | Contract manufacturer, Manufacturer, Repackager or relabeler | 2 | February 14, 2001 | 0 | 0 | 0 | api.fda.gov |
| Shandong Huge Dental Material Corporation | Rizhao Shandong, China | Manufacturer | 2 | November 3, 2020 | 0 | 0 | 0 | api.fda.gov |
| Sterngold Dental LLC | Attleboro, MA, United States | Manufacturer | 2 | January 24, 2002 | 0 | 0 | 0 | api.fda.gov |
| Zest Anchors, LLC | Carlsbad, CA, United States | Repackager or relabeler, Specification developer | 2 | September 11, 2019 | 0 | 0 | 0 | api.fda.gov |
| Zirkonzahn SRL | Gais Bolzano, Italy | Manufacturer | 2 | July 8, 2020 | 0 | 0 | 0 | api.fda.gov |
| ARUM DENTISTRY Co., Ltd. | Yuseong-gu Daejeon, South Korea | Manufacturer | 1 | December 8, 2021 | 0 | 0 | 0 | api.fda.gov |
| Asiga | Alexandria New South Wales, Australia | Manufacturer | 1 | May 5, 2025 | 0 | 0 | 0 | api.fda.gov |
| Amann Girrbach AG | Maeder Vorarlberg, Austria | Exporter to the US, Manufacturer | 1 | October 4, 2019 | 0 | 0 | 0 | api.fda.gov |
| Bego Bremer Goldschlaegerei Wilh. Herbst GMBH & Co. KG | Bremen, Germany | Manufacturer | 1 | May 18, 2020 | 0 | 0 | 0 | api.fda.gov |
| Bioloren SRL | SARONNO Varese, Italy | Manufacturer | 1 | November 8, 2011 | 0 | 0 | 0 | api.fda.gov |
| Blue Dent Dental | Pirassununga Sao Paulo, Brazil | Manufacturer, Repackager or relabeler | 1 | December 13, 2018 | 0 | 0 | 0 | api.fda.gov |
| Coltene/Whaledent AG | ALTSTAETTEN Sankt Gallen, Switzerland | Manufacturer | 1 | May 13, 2004 | 0 | 0 | 0 | api.fda.gov |
| Degudent GMBH | HANAU Hesse, Germany | Manufacturer | 1 | December 16, 2010 | 0 | 0 | 0 | api.fda.gov |
| Deltamed GMBH | FRIEDBERG Hesse, Germany | Manufacturer | 1 | July 31, 2020 | 0 | 0 | 0 | api.fda.gov |
| Dental Manufacturing SPA | Badia Polesine Rovigo, Italy | Exporter to the US, Manufacturer | 1 | November 5, 2020 | 0 | 0 | 0 | api.fda.gov |
| Dental Plus Usa, LLC | South Jordan, UT, United States | Repackager or relabeler, Reprocessor | 1 | May 12, 2023 | 0 | 0 | 0 | api.fda.gov |
| Dental Technologies, Inc. | Lincolnwood, IL, United States | Manufacturer | 1 | February 21, 1996 | 0 | 0 | 0 | api.fda.gov |
| Dentca, Inc. | Irvine, CA, United States | Manufacturer | 1 | February 5, 2020 | 0 | 0 | 0 | api.fda.gov |
| Dentis Co., Ltd. | Daegu, South Korea | Manufacturer | 1 | December 7, 2018 | 0 | 0 | 0 | api.fda.gov |
| Dentscare Ltda | Joinville Santa Catarina, Brazil | Manufacturer | 1 | November 26, 2024 | 0 | 0 | 0 | api.fda.gov |
| Dentsply Industria E Comercio Ltda | PIRASSUNUNGA Sao Paulo, Brazil | Manufacturer | 1 | December 16, 2010 | 0 | 0 | 0 | api.fda.gov |
| DMP Dental Industry S.A. | Markopoulo Attiki, Greece | Contract manufacturer, Manufacturer | 1 | September 2, 2020 | 0 | 0 | 0 | api.fda.gov |
| Dreve Dentamid GMBH | UNNA North Rhine-Westphalia, Germany | Manufacturer | 1 | May 31, 2024 | 0 | 0 | 0 | api.fda.gov |
| Enlighten Materials Co., Ltd. | Taipei City, Taiwan | Specification developer | 1 | May 5, 2020 | 0 | 0 | 0 | api.fda.gov |
| Evoden Industria Comercio Importacao E Exportacao De Produtos Odontologicos Ltda. | Pirassununga Sao Paulo, Brazil | Manufacturer | 1 | April 22, 2025 | 0 | 0 | 0 | api.fda.gov |
| Formlabs Inc. | Somerville, MA, United States | Complaint file establishment, Specification developer | 1 | July 19, 2024 | 0 | 0 | 0 | api.fda.gov |
| Formlabs Ohio, Inc. | Millbury, OH, United States | Complaint file establishment, Manufacturer | 1 | July 19, 2024 | 0 | 0 | 0 | api.fda.gov |
| GC Europe N.V. | LEUVEN Vlaams Brabant, Belgium | Manufacturer | 1 | July 9, 2020 | 0 | 0 | 0 | api.fda.gov |
| Guangzhou Heygears Imc.inc | Guangzhou Guangdong, China | Specification developer | 1 | January 14, 2022 | 0 | 0 | 0 | api.fda.gov |
| Hangzhou Shining3d Dental Technology Co., Ltd | Hangzhou Zhejiang, China | Manufacturer | 1 | April 17, 2026 | 0 | 0 | 0 | api.fda.gov |
| Huliang (shanghai) Bio-Tech Co., Ltd. | Shanghai, China | Manufacturer | 1 | May 12, 2023 | 0 | 0 | 0 | api.fda.gov |
| Imagine Milling Technologies, LLC | Chantilly, VA, United States | Remanufacturer, Repackager or relabeler | 1 | December 12, 2018 | 0 | 0 | 0 | api.fda.gov |
| Institut Straumann AG | BASEL Basel-Stadt, Switzerland | Specification developer | 1 | August 21, 2007 | 0 | 0 | 0 | api.fda.gov |
| J. Morita Usa, Inc. | Irvine, CA, United States | Repackager or relabeler, Specification developer | 1 | March 4, 2002 | 0 | 0 | 0 | api.fda.gov |
| Kettenbach GMBH & Co KG | ESCHENBURG Hesse, Germany | Manufacturer | 1 | December 27, 2012 | 0 | 0 | 0 | api.fda.gov |
| Kulzer GMBH | HANAU Hesse, Germany | Exporter to the US, Manufacturer | 1 | May 23, 2024 | 0 | 0 | 0 | api.fda.gov |
| Kerr Italia, S.r.l. | SCAFATI Salerno, Italy | Manufacturer | 1 | August 1, 2002 | 0 | 0 | 0 | api.fda.gov |
| Keystone Industries | Myerstown, PA, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 1 | June 25, 1996 | 0 | 0 | 0 | api.fda.gov |
| Keystone Industries - Gibbstown | Gibbstown, NJ, United States | Manufacturer | 1 | June 25, 1996 | 0 | 0 | 0 | api.fda.gov |
| Liaoning Upcera Co.,Ltd | Benxi Liaoning, China | Manufacturer | 1 | March 2, 2026 | 0 | 0 | 0 | api.fda.gov |
| Major Prodotti Dentari S.P.A. | MONCALIERI Torino, Italy | Manufacturer | 1 | December 9, 2008 | 0 | 0 | 0 | api.fda.gov |
| Mgnewton Ltd. | Gyengsan-si Gyeongbuk, South Korea | Manufacturer | 1 | December 21, 2022 | 0 | 0 | 0 | api.fda.gov |
| Micerium S.P.A. | AVEGNO Genova, Italy | Manufacturer | 1 | February 7, 2011 | 0 | 0 | 0 | api.fda.gov |
| Neo Dental Chemical Products Co., Ltd. | Nagano, Japan | Manufacturer | 1 | September 7, 2011 | 0 | 0 | 0 | api.fda.gov |
| New Stetic | GUARNE Antioquia, Colombia | Manufacturer | 1 | November 7, 2019 | 0 | 0 | 0 | api.fda.gov |
| POLIDENT d.o.o., Dental products industry | VOLCJA DRAGA Rence-Vogrsko, Slovenia | Manufacturer | 1 | August 28, 2012 | 0 | 0 | 0 | api.fda.gov |
| Pro3dure Medical GMBH | Iserlohn North Rhine-Westphalia, Germany | Manufacturer | 1 | November 5, 2020 | 0 | 0 | 0 | api.fda.gov |
| PSP Dental Co., Ltd. | Belvedere, Kent, United Kingdom | Complaint file establishment, Manufacturer, Repackager or relabeler | 1 | April 3, 1986 | 0 | 0 | 0 | api.fda.gov |
| Reliance Orthodontic Products, Inc. | Itasca, IL, United States | Contract manufacturer, Specification developer | 1 | February 26, 1988 | 0 | 0 | 0 | api.fda.gov |
| Rizhao Huge Biomaterials Company, Ltd. | Rizhao Shandong, China | Manufacturer | 1 | June 23, 2025 | 0 | 0 | 0 | api.fda.gov |
| Schuetz Dental GMBH | ROSBACH Hesse, Germany | Manufacturer | 1 | February 12, 2015 | 0 | 0 | 0 | api.fda.gov |
| Scientific Pharmaceuticals, Inc. | Pomona, CA, United States | Contract manufacturer, Manufacturer | 1 | August 4, 2004 | 0 | 0 | 0 | api.fda.gov |
| Spident Co., Ltd. | INCHEON Gyeonggi, South Korea | Manufacturer | 1 | March 10, 2022 | 0 | 0 | 0 | api.fda.gov |
| Sprintray Inc. | Los Angeles, CA, United States | Manufacturer | 1 | November 26, 2024 | 0 | 0 | 0 | api.fda.gov |
| Sprintray Inc. | Huntington Beach, CA, United States | Specification developer | 1 | November 26, 2024 | 0 | 0 | 0 | api.fda.gov |
| Solventum Germany GmbH | Kamen North Rhine-Westphalia, Germany | Complaint file establishment, Specification developer | 1 | January 9, 2008 | 0 | 0 | 0 | api.fda.gov |
| Talladium, Inc. | Santa Clarita, CA, United States | Manufacturer | 1 | April 24, 2015 | 0 | 1 | 0 | api.fda.gov |
| Union Dental S.A. | TIELMES Madrid(Province), Spain | Manufacturer | 1 | August 14, 2015 | 0 | 0 | 0 | api.fda.gov |
| Vita Zahnfabrik H. Rauter GMBH & Co. KG. | BAD SACKINGEN Baden-Wurttemberg, Germany | Manufacturer, Repackager or relabeler | 1 | June 1, 2007 | 0 | 0 | 0 | api.fda.gov |
| Whitepeaks Dental Solutions GMBH | Hamminkeln North Rhine-Westphalia, Germany | Manufacturer | 1 | December 18, 2013 | 0 | 0 | 0 | api.fda.gov |
| Yamahachi Dental MFG. Co. | Gamagori City Aichi, Japan | Complaint file establishment, Specification developer | 1 | November 23, 2015 | 0 | 0 | 0 | api.fda.gov |
| Yamahachi Dental Material (Changshu) Co., Ltd. | Changshu city Jiangsu, China | Manufacturer | 1 | November 23, 2015 | 0 | 0 | 0 | api.fda.gov |
| etkon GMBH | Markkleeberg Saxony, Germany | Manufacturer | 1 | August 21, 2007 | 0 | 0 | 0 | api.fda.gov |
| Bicon, LLC | Boston, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Clemde S.A. De C.V. | MEXICO, DF Ciudad de Mexico, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Contech Medical, Inc. | Providence, RI, 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 | |
| Dentsply Sirona Orthodontics Inc. | Sarasota, FL, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Graphenano Dental, SL | Paterna Valencia(Province), Spain | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Graphy Inc. | Seoul, South Korea | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Identa Dental Material GMBH | CUXHAVEN Lower Saxony, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ivoclar Vivadent Manufacturing GmbH | NATURNO (BZ) Bolzano, Italy | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ivoclar Vivadent Manufacturing, Inc | Somerset, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangxi Heygears Innovative Material Co., Ltd | Jiujiang Jiangxi, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kulzer GMBH | WEHRHEIM Hesse, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kerr Corporation | Pomona, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Keystone Industries | Cherry Hill, NJ, United States | 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 | |
| Manufacturera Dental Continental | ZAPOPAN Jalisco, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Midwest Tek | New Albany, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Prevest Denpro Limited | Jammu Jammu and Kashmir, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Saremco Dental AG | 9445 Rebstein Sankt Gallen, Switzerland | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SDS de Mexico S. de R.L. de C.V. | MEXICALI, B.C. C.P. Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Piocreat 3D Technology Co., Ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shiga Shofu Inc. | Koka Shiga, Japan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shofu Inc. | FUKUINE, HIGASHIYAMA-KU Kyoto, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Solventum Us LLC | Eagan, MN, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stratasys Ltd | Kiryat Gat Southern, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| STRATASYS LTD - Headquarter | Rehovot Central, Israel | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Jiahong Dental Technology Co., Ltd | Shenzhen Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Solventum US LLC | San Antonio, TX, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Solventum US LLC | Irvine, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Straumann Manufacturing, Inc. | Mansfield, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vertex-Dental B.V. | Soesterberg Utrecht, Netherlands | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yates-Motloid | Elmhurst, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 17, 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.