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Data / Medical devices / Material, Impression Tray, Resin

Material, Impression Tray, Resin (EBH): 142 FDA-registered makers in 22 countries

142 establishments in 22 countries are registered with the FDA to make Material, Impression Tray, Resin (product code EBH, Class 1, 21 CFR 872.3670). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 30 510(k) clearances under this code, the latest on January 26, 1994, and lists 0 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
EBH
Device class
1
Regulation
872.3670
Medical specialty
Dental

Makers by country

CountryMakers
China39
United States32
Germany19
Pakistan12
South Korea12
Taiwan5
United Kingdom3
Italy3
Turkey2
India2
Brazil2
Australia1
Greece1
Vietnam1
Liechtenstein1
Colombia1
Hong Kong1
Israel1
Norway1
Spain1
Netherlands1
Japan1

Makers of Material, Impression Tray, 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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Kulzer GMBHHANAU Hesse, GermanyExporter to the US, Manufacturer1June 6, 1991000api.fda.gov
PSP Dental Co., Ltd.Belvedere, Kent, United KingdomComplaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler1September 6, 1985000api.fda.gov
Solventum Germany GmbHSEEFELD Bavaria, GermanyManufacturer1March 9, 1988000api.fda.gov
3bfab Teknoloji Anonim SirketiIstanbul, TurkeyManufacturer0000api.fda.gov
Accompany SurgicalSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Aidite (qinhuangdao) Technology Co., LtdQinhuangdao City Hebei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Airway Management Inc.Farmers Branch, TX, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Anqing Clean Dental Instrument Technology Co.,ltdAnqing City Anhui, ChinaExporter to the US, Manufacturer0000api.fda.gov
Apply Labwork Inc.Taoyuan City, TaiwanManufacturer0000api.fda.gov
AsigaAlexandria New South Wales, AustraliaManufacturer0000api.fda.gov
Associated Dental Products LtdSwindon Wiltshire, United KingdomManufacturer0000api.fda.gov
BH Medical Products Co., LtdChangzhou City Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Buffalo Dental Mfg Co IncHancock, NY, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Changzhou OU Nuo Medical Equipment Co., Ltd.Changzhou City Jiangsu, ChinaManufacturer0000api.fda.gov
Debo Medical Technology (shijiazhuang) Co., Ltd.Shijiazhuang Hebei, ChinaContract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler0000api.fda.gov
Deltamed GMBHFRIEDBERG Hesse, GermanyManufacturer0000api.fda.gov
Dent A Pharm Produktionsgesellschaft MBHBarmstedt Schleswig-Holstein, GermanyManufacturer0000api.fda.gov
Denta Craft InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Dental Technologies, Inc.Lincolnwood, IL, United StatesManufacturer0000api.fda.gov
Dentall, Inc.District, Beijing, ChinaManufacturer0000api.fda.gov
Dentis Co., Ltd.Daegu, South KoreaManufacturer0000api.fda.gov
Dentona AGDortmund North Rhine-Westphalia, GermanyManufacturer0000api.fda.gov
Dentsply LLCMilford, DE, United StatesManufacturer0000api.fda.gov
Deprag High Tech Materials ( Zhengzhou ) Co.,ltd.ZHANGZHOU Henan, ChinaManufacturer0000api.fda.gov
Detax GMBHETTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Discus Dental, LLCOntario, CA, United StatesManufacturer0000api.fda.gov
DMG Chemisch Pharmazeutische Fabrik GMBHHamburg, GermanyManufacturer0000api.fda.gov
DMG Digital Enterprises SeHamburg, GermanyManufacturer0000api.fda.gov
DMP Dental Industry S.A.Markopoulo Attiki, GreeceContract manufacturer, Manufacturer0000api.fda.gov
Dreve Dentamid GMBHUNNA North Rhine-Westphalia, GermanyManufacturer0000api.fda.gov
DXM Co., Ltd.Jeonnam-Gwangju Special Metropolitan City, South KoreaManufacturer0000api.fda.gov
Elite Dental LabHuizhou City Guangdong, ChinaManufacturer0000api.fda.gov
Enlighten Materials Co., Ltd.Taipei City, TaiwanSpecification developer0000api.fda.gov
Fricke Dental MFG. Co.Streamwood, IL, United StatesManufacturer0000api.fda.gov
Formlabs Inc.Somerville, MA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Formlabs Ohio, Inc.Millbury, OH, United StatesManufacturer0000api.fda.gov
Garish ApparelsWazirabad Punjab, PakistanManufacturer0000api.fda.gov
GC America Inc.Alsip, IL, United StatesManufacturer0000api.fda.gov
Guangzhou Heygears Imc.incGuangzhou Guangdong, ChinaSpecification developer0000api.fda.gov
Guilin Kevin Peter Technology Co., Ltd.Guilin Guangxi, ChinaManufacturer0000api.fda.gov
Hager Worldwide, Inc.Hickory, NC, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Handae Chemical Co., LtdJincheon-gun Chungbuk, South KoreaManufacturer0000api.fda.gov
Hangzhou Shining3d Dental Technology Co., LtdHangzhou Zhejiang, ChinaManufacturer0000api.fda.gov
Hdi Inc.Seongnam-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Ho Chi Minh Branch - Vatech Viet Joint Stock CompanyThanh My Tay Ward Ho Chi Minh, VietnamManufacturer0000api.fda.gov
Huaian Tisurg Medical Instruments Co., Ltd.Huaian City Jiangsu, ChinaManufacturer0000api.fda.gov
Hubei Guarddent Medical Technology Co.,ltdWuhan Hubei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Identa Dental Material GMBHCUXHAVEN Lower Saxony, GermanyContract manufacturer0000api.fda.gov
Imicryl Dis Malzemeleri Sanayi Ve Ticaret A.S.Konya, TurkeyManufacturer0000api.fda.gov
Improve Co.,limitedLantau Island Hong Kong, ChinaManufacturer0000api.fda.gov
Innovation Meditech GMBHUNNA North Rhine-Westphalia, GermanyContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Ivoclar Vivadent AGSchaan, LiechtensteinContract manufacturer, Manufacturer, Specification developer0000api.fda.gov
Ivoclar Vivadent Manufacturing GmbHNATURNO (BZ) Bolzano, ItalyContract manufacturer0000api.fda.gov
Jamesb Dental StudioDumont, NJ, United StatesManufacturer0000api.fda.gov
Jiangxi Heygears Innovative Material Co., LtdJiujiang Jiangxi, ChinaContract manufacturer0000api.fda.gov
Kettenbach GMBH & Co KGESCHENBURG Hesse, GermanyManufacturer0000api.fda.gov
Keystone IndustriesMyerstown, PA, United StatesManufacturer0000api.fda.gov
Keystone IndustriesCherry Hill, NJ, United StatesManufacturer0000api.fda.gov
Keystone Industries - GibbstownGibbstown, NJ, United StatesManufacturer0000api.fda.gov
Lang Dental MFG. Co., Inc.Wheeling, IL, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Laparomed Private LimitedMumbai Maharashtra, IndiaManufacturer0000api.fda.gov
Liaoning Xinaite Technology Co.,ltdbenxi Liaoning, ChinaManufacturer0000api.fda.gov
Lohar Medical CompanySialkot Punjab, PakistanManufacturer0000api.fda.gov
Loyol New Material Suhzou Co.,Ltd.Suzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Major Prodotti Dentari S.P.A.MONCALIERI Torino, ItalyManufacturer, Repackager or relabeler0000api.fda.gov
Maquira Industria De Produtos OdontologicosMaringa Parana, BrazilManufacturer0000api.fda.gov
Medcave Private LimitedSialkot Punjab, PakistanManufacturer0000api.fda.gov
Megadenta Dentalprodukte GMBHRADEBERG Saxony, GermanyManufacturer0000api.fda.gov
Merz Dental GMBHLUETJENBURG Schleswig-Holstein, GermanyManufacturer0000api.fda.gov
Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda.SAO CARLOS Sao Paulo, BrazilManufacturer0000api.fda.gov
Monitex Industrial Co., Ltd.SAN-CHUNG CITY Taipei, TaiwanContract manufacturer0000api.fda.gov
Mount Blonck TradingSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Nadir & Co.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Nanjing Chamlion Laser Technology Co., Ltd.Nanjing Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Nanova Biomaterials IncColumbia, MO, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
New SteticGUARNE Antioquia, ColombiaManufacturer0000api.fda.gov
Nucare LLCMontclair, CA, United StatesSpecification developer0000api.fda.gov
One Day Dental PartnerSuncheon-si Jeonnam, South KoreaExporter to the US, Manufacturer0000api.fda.gov
Orthguide Medical Technology (jiangsu) Co., LtdWuxi City Jiangsu, ChinaContract manufacturer, Specification developer0000api.fda.gov
Pac-Dent Inc.Brea, CA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Pacific Care Limited / Pacificare Asia LimitedHong Kong, Hong KongManufacturer0000api.fda.gov
Panorama International.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Perflex LtdNetanya Central, IsraelManufacturer0000api.fda.gov
Philips Oral Healthcare, LLCBothell, WA, United StatesSpecification developer0000api.fda.gov
Plasdent Shanghai Co., Ltd.Shanghai, ChinaManufacturer0000api.fda.gov
PNUAdd Co., Ltd.Busan, South KoreaManufacturer0000api.fda.gov
Prime Dental Manufacturing, Inc.Chicago, IL, United StatesManufacturer0000api.fda.gov
Pro3dure Medical GMBHIserlohn North Rhine-Westphalia, GermanyManufacturer0000api.fda.gov
Pulpdent CorporationWatertown, MA, United StatesManufacturer0000api.fda.gov
Power Dental USA, Inc.McHenry, IL, United StatesManufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
Ray Co., LtdYongin-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Renewmedical Co., Ltd.Bucheon-si, Gyeonggi-do, South KoreaManufacturer0000api.fda.gov
Richbolt EnterprisesSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Riton 3D Technology Co., LtdGuangzhou Guangdong, ChinaManufacturer0000api.fda.gov
S & C Polymer GMBHELMSHORN Schleswig-Holstein, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Sabri IndustriesSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Scientific Pharmaceuticals, Inc.Pomona, CA, United StatesManufacturer0000api.fda.gov
Seilglobal Co., LtdBusan Gyeongnam, South KoreaManufacturer0000api.fda.gov
Shanghai Lions Industrial Co.,ltd.Shanghai, ChinaContract manufacturer, Exporter to the US0000api.fda.gov
Shengiho Enterprise Co., Ltd.Taichung City, TaiwanManufacturer0000api.fda.gov
Shenzhen Jinyi Medical Technology Co.,ltdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Moye Technology Co LtdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Piocreat 3D Technology Co., LtdShenzhen Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Shenzhen Yongchanghe Technology Co., Ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Signor Seven InternationalSialkot Punjab, PakistanManufacturer0000api.fda.gov
SMD Dental LaboratoryHeungdeok-gu Cheongju-si Chungbuk, South KoreaManufacturer0000api.fda.gov
Smilden Biotechnology Co., Ltd.New Taipei City, TaiwanManufacturer0000api.fda.gov
Spident Co., Ltd.INCHEON Gyeonggi, South KoreaManufacturer0000api.fda.gov
Sprintray Inc.Los Angeles, CA, United StatesManufacturer0000api.fda.gov
Sprintray Inc.Huntington Beach, CA, United StatesManufacturer, Specification developer0000api.fda.gov
Suzhou Laixin 3D Technology Co.,ltdSuzhou Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Saga Dental Supply ASKongsvinger Hedmark, NorwayManufacturer0000api.fda.gov
Shandong Huge Dental Material CorporationRizhao Shandong, ChinaManufacturer0000api.fda.gov
Shanghai Coherz Technologies Co., Ltd.Shanghai, ChinaManufacturer0000api.fda.gov
Shanghai Jolly Industrial Co., Ltd.Shanghai, ChinaContract manufacturer, Exporter to the US0000api.fda.gov
Solventum Germany GmbHKamen North Rhine-Westphalia, GermanyManufacturer0000api.fda.gov
Solventum Orthodontics CorporationMonrovia, CA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Sterngold Dental LLCAttleboro, MA, United StatesManufacturer0000api.fda.gov
Suzhou Pac-Dent Technology Co., LtdSUZHOU CITY Jiangsu, ChinaContract manufacturer0000api.fda.gov
Tangshan Zhengtong Exhibition Co., Ltd.Tangshan Hebei, ChinaManufacturer0000api.fda.gov
TC Dental & Medical Supplies, Inc.Anaheim, CA, United StatesSpecification developer0000api.fda.gov
Tianjin Water Source Tech Co., Ltd.Tianjin, ChinaManufacturer0000api.fda.gov
TP Orthodontics, Inc.La Porte, IN, United StatesManufacturer0000api.fda.gov
The Belport Company, Inc DBA Gingi-PakCamarillo, CA, United StatesManufacturer0000api.fda.gov
Union Dental S.A.TIELMES Madrid(Province), SpainManufacturer0000api.fda.gov
Ustomed Instrumente GMBH & Co. KGTuttlingen Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Ultradent Products Inc.South Jordan, UT, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Vericom Co., Ltd.Chuncheon-Si Gangwon, South KoreaManufacturer0000api.fda.gov
Vertex-Dental B.V.Soesterberg Utrecht, NetherlandsManufacturer0000api.fda.gov
Voco GMBHCUXHAVEN Lower Saxony, GermanyManufacturer, Repackager or relabeler0000api.fda.gov
Vedia Solutions, Division of Laxmi Dental LimitedPalghar Maharashtra, IndiaManufacturer, Repackager or relabeler0000api.fda.gov
Whip-Mix Corp.Louisville, KY, United StatesManufacturer0000api.fda.gov
Wright Health GroupDundee Dundee City, United KingdomManufacturer, Repackager or relabeler0000api.fda.gov
Weldon InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Xiamen Antinsky Industry Co., LtdXiamen Fujian, ChinaExporter to the US, Manufacturer0000api.fda.gov
Xiamen Zhiyuan Medical Technology Co., Ltd.XIAMEN Fujian, ChinaManufacturer0000api.fda.gov
Yamahachi Dental MFG. Co.Gamagori City Aichi, JapanComplaint file establishment, Manufacturer0000api.fda.gov
Yamahachi Dental Material (Changshu) Co., Ltd.Changshu city Jiangsu, ChinaManufacturer0000api.fda.gov
Zhengzhou Huaer Electro-Optics Technology Co., Ltd.Zhengzhou Henan, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Zirkonzahn SRLGais Bolzano, ItalyManufacturer0000api.fda.gov
Ziyang Rayform Technology Co., LtdZiyang City Sichuan, ChinaManufacturer0000api.fda.gov
ZOGEAR Medical Co., Ltd.Yizheng Jiangsu, ChinaManufacturer0000api.fda.gov

Updated January 26, 1994. 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.