Data / Medical devices / Activator, Ultraviolet, For Polymerization
Activator, Ultraviolet, For Polymerization (EBZ): 59 FDA-registered makers in 17 countries
59 establishments in 17 countries are registered with the FDA to make Activator, Ultraviolet, For Polymerization (product code EBZ, Class 2, 21 CFR 872.6070). 47 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 214 510(k) clearances under this code, the latest on June 18, 2026, and lists 4 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- EBZ
- Device class
- 2
- Regulation
- 872.6070
- Medical specialty
- Dental
Makers by country
| Country | Makers |
|---|---|
| United States | 18 |
| South Korea | 7 |
| Taiwan | 6 |
| China | 6 |
| Germany | 5 |
| Japan | 3 |
| Austria | 3 |
| Switzerland | 2 |
| France | 1 |
| Liechtenstein | 1 |
| Canada | 1 |
| Denmark | 1 |
| Italy | 1 |
| Hong Kong | 1 |
| Australia | 1 |
| Czechia | 1 |
| Mexico | 1 |
Makers of Activator, Ultraviolet, For Polymerization
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 |
|---|---|---|---|---|---|---|---|---|
| Satelec-Acteon Group | MERIGNAC Gironde, France | Manufacturer | 6 | April 11, 2014 | 0 | 0 | 0 | api.fda.gov |
| Ultradent Products Inc. | South Jordan, UT, United States | Manufacturer | 6 | February 22, 2022 | 0 | 0 | 0 | api.fda.gov |
| Dentmate Technology Co., Ltd. | New Taipei, Taiwan | Manufacturer | 4 | September 16, 2022 | 0 | 0 | 0 | api.fda.gov |
| Good Doctors Co., Ltd. | Incheon Seoul, South Korea | Manufacturer | 4 | August 4, 2023 | 0 | 0 | 0 | api.fda.gov |
| Apoza Enterprise Co., Ltd. | Hsin-Chuang District New Taipei, Taiwan | Manufacturer | 3 | March 2, 2007 | 0 | 0 | 0 | api.fda.gov |
| Bonart Co. Ltd. | Keelung, Taiwan | Contract manufacturer, Manufacturer | 3 | November 13, 2008 | 0 | 0 | 0 | api.fda.gov |
| Den-Mat Holdings, LLC | Lompoc, CA, United States | Complaint file establishment, Manufacturer | 3 | November 21, 2008 | 0 | 0 | 0 | api.fda.gov |
| DXM Co., Ltd. | Jeonnam-Gwangju Special Metropolitan City, South Korea | Manufacturer | 3 | January 10, 2020 | 0 | 0 | 0 | api.fda.gov |
| Kulzer GMBH | HANAU Hesse, Germany | Exporter to the US, Specification developer | 3 | December 7, 2009 | 0 | 0 | 0 | api.fda.gov |
| Solventum Germany GmbH | SEEFELD Bavaria, Germany | Manufacturer, Repackager or relabeler, Specification developer | 3 | May 16, 2001 | 0 | 0 | 0 | api.fda.gov |
| Coltene/Whaledent Inc. | Cuyahoga Falls, OH, United States | Contract manufacturer, Manufacturer, Specification developer | 2 | November 27, 2012 | 0 | 0 | 0 | api.fda.gov |
| Dentlight Inc. | Plano, TX, United States | Manufacturer | 2 | April 19, 2019 | 0 | 0 | 0 | api.fda.gov |
| Dentsply LLC | Milford, DE, United States | Manufacturer, Specification developer | 2 | November 20, 2019 | 0 | 0 | 0 | api.fda.gov |
| Foshan Coxo Medical Instrument Co., Ltd. | Foshan Guangdong, China | Manufacturer | 2 | April 11, 2025 | 0 | 0 | 0 | api.fda.gov |
| Ivoclar Vivadent AG | Schaan, Liechtenstein | Manufacturer, Specification developer | 2 | July 3, 2019 | 0 | 0 | 0 | api.fda.gov |
| Kerr Corporation | Orange, CA, United States | Complaint file establishment, Specification developer | 2 | July 18, 2017 | 0 | 0 | 0 | api.fda.gov |
| Addent, Inc. | Danbury, CT, United States | Manufacturer | 1 | June 23, 2006 | 0 | 0 | 0 | api.fda.gov |
| Allure Ortho | Whitinsville, MA, United States | Specification developer | 1 | September 16, 2022 | 0 | 0 | 0 | api.fda.gov |
| Beyes Dental Inc | Toronto Ontario, Canada | Manufacturer | 1 | March 19, 2008 | 0 | 0 | 0 | api.fda.gov |
| Cao Group, Inc. | W Jordan, UT, United States | Manufacturer, Manufacturer for export | 1 | June 12, 2006 | 0 | 0 | 0 | api.fda.gov |
| Changzhou Sifary Medical Technology Co., Ltd. | Changzhou Jiangsu, China | Manufacturer | 1 | November 23, 2022 | 0 | 0 | 0 | api.fda.gov |
| CMS Dental A/S | Roslev Midtjylland, Denmark | Manufacturer | 1 | November 28, 2000 | 0 | 0 | 0 | api.fda.gov |
| Dent4you AG | Heerbrugg Sankt Gallen, Switzerland | Specification developer | 1 | December 22, 2022 | 0 | 0 | 0 | api.fda.gov |
| DENTALL Co., Ltd. | Bucheon-si Gyeonggi, South Korea | Manufacturer | 1 | August 8, 2017 | 0 | 0 | 0 | api.fda.gov |
| DENTSPLY DETREY GmbH | KONSTANZ Baden-Wurttemberg, Germany | Manufacturer | 1 | June 24, 2004 | 0 | 0 | 0 | api.fda.gov |
| Dhef Inc. | New Taipei City, Taiwan | Manufacturer | 1 | January 2, 1996 | 0 | 0 | 0 | api.fda.gov |
| Diadent Group International | CHONGJU CITY Chungbuk, South Korea | Manufacturer | 1 | August 7, 2020 | 0 | 0 | 0 | api.fda.gov |
| Dmetec Co., Ltd | Bucheon Gyeonggi, South Korea | Manufacturer | 1 | July 19, 2005 | 0 | 0 | 0 | api.fda.gov |
| Foshan CICADA Dental Instrument Co., Ltd. | Foshan Guangdong, China | Manufacturer | 1 | February 13, 2020 | 0 | 0 | 0 | api.fda.gov |
| Garrison Dental Solutions | Spring Lake, MI, United States | Complaint file establishment, Specification developer | 1 | August 1, 2024 | 0 | 0 | 0 | api.fda.gov |
| GC Corp. | ITABASHI-KU Tokyo, Japan | Manufacturer | 1 | February 3, 2005 | 0 | 0 | 0 | api.fda.gov |
| GC Corporation-Fuji Oyama Factory | SUNTO-GUN, Shizuoka-Ken, Japan | Manufacturer | 1 | February 3, 2005 | 0 | 0 | 0 | api.fda.gov |
| GENOSS Co., Ltd. | Suwon-si Gyeonggi, South Korea | Manufacturer | 1 | May 5, 2025 | 0 | 0 | 0 | api.fda.gov |
| Guilin Refine Medical Instrument Co., Ltd. | Guilin Guangxi, China | Manufacturer | 1 | November 15, 2023 | 0 | 0 | 0 | api.fda.gov |
| Guilin Woodpecker Medical Instrument Co., Ltd | GUILIN CITY Guangxi, China | Manufacturer | 1 | March 19, 2008 | 0 | 0 | 0 | api.fda.gov |
| Handpiece Headquarters - HPR Inc. | Placentia, CA, United States | Specification developer | 1 | November 2, 2023 | 0 | 1 | 0 | api.fda.gov |
| Inter-Med, Inc. | Racine, WI, United States | Specification developer | 1 | June 8, 2017 | 0 | 0 | 0 | api.fda.gov |
| Mectron S.P.A. | CARASCO Genova, Italy | Manufacturer | 1 | December 7, 2009 | 0 | 0 | 0 | api.fda.gov |
| META SYSTEMS CO., LTD also doing business as S-Denti Co.,Ltd | Seongnam-si Gyeonggi, South Korea | Manufacturer | 1 | October 14, 2025 | 0 | 0 | 0 | api.fda.gov |
| Monitex Industrial Co., Ltd. | SAN-CHUNG CITY Taipei, Taiwan | Contract manufacturer, Manufacturer | 1 | April 7, 2017 | 0 | 0 | 0 | api.fda.gov |
| Parkell, Inc. | Edgewood, NY, United States | Manufacturer | 1 | November 28, 2006 | 0 | 0 | 0 | api.fda.gov |
| Premium Plus (dongguan) Limited | Dongguan Guangdong, China | Manufacturer | 1 | April 10, 2025 | 0 | 0 | 0 | api.fda.gov |
| Premium Plus International Limited | Hong Kong, Hong Kong | Manufacturer | 1 | August 22, 2016 | 0 | 0 | 0 | api.fda.gov |
| Rolence Ent. Inc. | CHUNGLI Taoyuan, Taiwan | Exporter to the US, Manufacturer | 1 | October 10, 2000 | 0 | 0 | 0 | api.fda.gov |
| Sdi Ltd. | BAYSWATER Victoria, Australia | Manufacturer | 1 | April 24, 2003 | 0 | 0 | 0 | api.fda.gov |
| Spring Health Products, Inc. | Norristown, PA, United States | Manufacturer | 1 | September 29, 1999 | 0 | 0 | 0 | api.fda.gov |
| Solventum Orthodontics Corporation | Monrovia, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | May 16, 2001 | 0 | 0 | 0 | api.fda.gov |
| Asi Medical, Inc. | Englewood, CO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| I-Dent Innovations For Dentistry SA | Nyon Vaud, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| IVOCLAR VIVADENT Manufacturing GmbH | BURS Vorarlberg, Austria | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| J. Morita MFG. Corp. | FUSHIMI-KU Kyoto, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kulzer GMBH | WEHRHEIM Hesse, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Miller Technical Services | Plymouth, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Proguard Health Inc. | Los Angeles, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Schott AG | Mainz Rhineland-Palatinate, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Schott CR, S.R.O. | Valasske Mezirici Zlinsky Kraj, Czechia | Contract 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 | |
| W&H Dentalwerk Buermoos GMBH | BUERMOOS Salzburg, Austria | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| W&H Dentalwerk Buermoos GMBH - Site 2 | BUERMOOS Salzburg, Austria | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 18, 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.