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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

CountryMakers
United States18
South Korea7
Taiwan6
China6
Germany5
Japan3
Austria3
Switzerland2
France1
Liechtenstein1
Canada1
Denmark1
Italy1
Hong Kong1
Australia1
Czechia1
Mexico1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Satelec-Acteon GroupMERIGNAC Gironde, FranceManufacturer6April 11, 2014000api.fda.gov
Ultradent Products Inc.South Jordan, UT, United StatesManufacturer6February 22, 2022000api.fda.gov
Dentmate Technology Co., Ltd.New Taipei, TaiwanManufacturer4September 16, 2022000api.fda.gov
Good Doctors Co., Ltd.Incheon Seoul, South KoreaManufacturer4August 4, 2023000api.fda.gov
Apoza Enterprise Co., Ltd.Hsin-Chuang District New Taipei, TaiwanManufacturer3March 2, 2007000api.fda.gov
Bonart Co. Ltd.Keelung, TaiwanContract manufacturer, Manufacturer3November 13, 2008000api.fda.gov
Den-Mat Holdings, LLCLompoc, CA, United StatesComplaint file establishment, Manufacturer3November 21, 2008000api.fda.gov
DXM Co., Ltd.Jeonnam-Gwangju Special Metropolitan City, South KoreaManufacturer3January 10, 2020000api.fda.gov
Kulzer GMBHHANAU Hesse, GermanyExporter to the US, Specification developer3December 7, 2009000api.fda.gov
Solventum Germany GmbHSEEFELD Bavaria, GermanyManufacturer, Repackager or relabeler, Specification developer3May 16, 2001000api.fda.gov
Coltene/Whaledent Inc.Cuyahoga Falls, OH, United StatesContract manufacturer, Manufacturer, Specification developer2November 27, 2012000api.fda.gov
Dentlight Inc.Plano, TX, United StatesManufacturer2April 19, 2019000api.fda.gov
Dentsply LLCMilford, DE, United StatesManufacturer, Specification developer2November 20, 2019000api.fda.gov
Foshan Coxo Medical Instrument Co., Ltd.Foshan Guangdong, ChinaManufacturer2April 11, 2025000api.fda.gov
Ivoclar Vivadent AGSchaan, LiechtensteinManufacturer, Specification developer2July 3, 2019000api.fda.gov
Kerr CorporationOrange, CA, United StatesComplaint file establishment, Specification developer2July 18, 2017000api.fda.gov
Addent, Inc.Danbury, CT, United StatesManufacturer1June 23, 2006000api.fda.gov
Allure OrthoWhitinsville, MA, United StatesSpecification developer1September 16, 2022000api.fda.gov
Beyes Dental IncToronto Ontario, CanadaManufacturer1March 19, 2008000api.fda.gov
Cao Group, Inc.W Jordan, UT, United StatesManufacturer, Manufacturer for export1June 12, 2006000api.fda.gov
Changzhou Sifary Medical Technology Co., Ltd.Changzhou Jiangsu, ChinaManufacturer1November 23, 2022000api.fda.gov
CMS Dental A/SRoslev Midtjylland, DenmarkManufacturer1November 28, 2000000api.fda.gov
Dent4you AGHeerbrugg Sankt Gallen, SwitzerlandSpecification developer1December 22, 2022000api.fda.gov
DENTALL Co., Ltd.Bucheon-si Gyeonggi, South KoreaManufacturer1August 8, 2017000api.fda.gov
DENTSPLY DETREY GmbHKONSTANZ Baden-Wurttemberg, GermanyManufacturer1June 24, 2004000api.fda.gov
Dhef Inc.New Taipei City, TaiwanManufacturer1January 2, 1996000api.fda.gov
Diadent Group InternationalCHONGJU CITY Chungbuk, South KoreaManufacturer1August 7, 2020000api.fda.gov
Dmetec Co., LtdBucheon Gyeonggi, South KoreaManufacturer1July 19, 2005000api.fda.gov
Foshan CICADA Dental Instrument Co., Ltd.Foshan Guangdong, ChinaManufacturer1February 13, 2020000api.fda.gov
Garrison Dental SolutionsSpring Lake, MI, United StatesComplaint file establishment, Specification developer1August 1, 2024000api.fda.gov
GC Corp.ITABASHI-KU Tokyo, JapanManufacturer1February 3, 2005000api.fda.gov
GC Corporation-Fuji Oyama FactorySUNTO-GUN, Shizuoka-Ken, JapanManufacturer1February 3, 2005000api.fda.gov
GENOSS Co., Ltd.Suwon-si Gyeonggi, South KoreaManufacturer1May 5, 2025000api.fda.gov
Guilin Refine Medical Instrument Co., Ltd.Guilin Guangxi, ChinaManufacturer1November 15, 2023000api.fda.gov
Guilin Woodpecker Medical Instrument Co., LtdGUILIN CITY Guangxi, ChinaManufacturer1March 19, 2008000api.fda.gov
Handpiece Headquarters - HPR Inc.Placentia, CA, United StatesSpecification developer1November 2, 2023010api.fda.gov
Inter-Med, Inc.Racine, WI, United StatesSpecification developer1June 8, 2017000api.fda.gov
Mectron S.P.A.CARASCO Genova, ItalyManufacturer1December 7, 2009000api.fda.gov
META SYSTEMS CO., LTD also doing business as S-Denti Co.,LtdSeongnam-si Gyeonggi, South KoreaManufacturer1October 14, 2025000api.fda.gov
Monitex Industrial Co., Ltd.SAN-CHUNG CITY Taipei, TaiwanContract manufacturer, Manufacturer1April 7, 2017000api.fda.gov
Parkell, Inc.Edgewood, NY, United StatesManufacturer1November 28, 2006000api.fda.gov
Premium Plus (dongguan) LimitedDongguan Guangdong, ChinaManufacturer1April 10, 2025000api.fda.gov
Premium Plus International LimitedHong Kong, Hong KongManufacturer1August 22, 2016000api.fda.gov
Rolence Ent. Inc.CHUNGLI Taoyuan, TaiwanExporter to the US, Manufacturer1October 10, 2000000api.fda.gov
Sdi Ltd.BAYSWATER Victoria, AustraliaManufacturer1April 24, 2003000api.fda.gov
Spring Health Products, Inc.Norristown, PA, United StatesManufacturer1September 29, 1999000api.fda.gov
Solventum Orthodontics CorporationMonrovia, CA, United StatesComplaint file establishment, Manufacturer, Specification developer1May 16, 2001000api.fda.gov
Asi Medical, Inc.Englewood, CO, United StatesManufacturer0000api.fda.gov
I-Dent Innovations For Dentistry SANyon Vaud, SwitzerlandContract manufacturer0000api.fda.gov
IVOCLAR VIVADENT Manufacturing GmbHBURS Vorarlberg, AustriaContract manufacturer0000api.fda.gov
J. Morita MFG. Corp.FUSHIMI-KU Kyoto, JapanManufacturer0000api.fda.gov
Kulzer GMBHWEHRHEIM Hesse, GermanyContract manufacturer0000api.fda.gov
Miller Technical ServicesPlymouth, MI, United StatesContract manufacturer0000api.fda.gov
Proguard Health Inc.Los Angeles, CA, United StatesContract manufacturer0000api.fda.gov
Schott AGMainz Rhineland-Palatinate, GermanyContract manufacturer0000api.fda.gov
Schott CR, S.R.O.Valasske Mezirici Zlinsky Kraj, CzechiaContract manufacturer0000api.fda.gov
SDS de Mexico S. de R.L. de C.V.MEXICALI, B.C. C.P. Baja California, MexicoContract manufacturer0000api.fda.gov
W&H Dentalwerk Buermoos GMBHBUERMOOS Salzburg, AustriaExporter to the US, Manufacturer0000api.fda.gov
W&H Dentalwerk Buermoos GMBH - Site 2BUERMOOS Salzburg, AustriaExporter to the US, Manufacturer0000api.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.