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
| Country | Makers |
|---|---|
| China | 39 |
| United States | 32 |
| Germany | 19 |
| Pakistan | 12 |
| South Korea | 12 |
| Taiwan | 5 |
| United Kingdom | 3 |
| Italy | 3 |
| Turkey | 2 |
| India | 2 |
| Brazil | 2 |
| Australia | 1 |
| Greece | 1 |
| Vietnam | 1 |
| Liechtenstein | 1 |
| Colombia | 1 |
| Hong Kong | 1 |
| Israel | 1 |
| Norway | 1 |
| Spain | 1 |
| Netherlands | 1 |
| Japan | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Kulzer GMBH | HANAU Hesse, Germany | Exporter to the US, Manufacturer | 1 | June 6, 1991 | 0 | 0 | 0 | api.fda.gov |
| PSP Dental Co., Ltd. | Belvedere, Kent, United Kingdom | Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler | 1 | September 6, 1985 | 0 | 0 | 0 | api.fda.gov |
| Solventum Germany GmbH | SEEFELD Bavaria, Germany | Manufacturer | 1 | March 9, 1988 | 0 | 0 | 0 | api.fda.gov |
| 3bfab Teknoloji Anonim Sirketi | Istanbul, Turkey | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Accompany Surgical | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aidite (qinhuangdao) Technology Co., Ltd | Qinhuangdao City Hebei, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Airway Management Inc. | Farmers Branch, TX, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anqing Clean Dental Instrument Technology Co.,ltd | Anqing City Anhui, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Apply Labwork Inc. | Taoyuan City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Asiga | Alexandria New South Wales, Australia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Associated Dental Products Ltd | Swindon Wiltshire, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BH Medical Products Co., Ltd | Changzhou City Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Buffalo Dental Mfg Co Inc | Hancock, NY, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changzhou OU Nuo Medical Equipment Co., Ltd. | Changzhou City Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Debo Medical Technology (shijiazhuang) Co., Ltd. | Shijiazhuang Hebei, China | Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Deltamed GMBH | FRIEDBERG Hesse, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dent A Pharm Produktionsgesellschaft MBH | Barmstedt Schleswig-Holstein, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Denta Craft Instruments | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dental Technologies, Inc. | Lincolnwood, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentall, Inc. | District, Beijing, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentis Co., Ltd. | Daegu, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentona AG | Dortmund North Rhine-Westphalia, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentsply LLC | Milford, DE, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Deprag High Tech Materials ( Zhengzhou ) Co.,ltd. | ZHANGZHOU Henan, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Detax GMBH | ETTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Discus Dental, LLC | Ontario, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DMG Chemisch Pharmazeutische Fabrik GMBH | Hamburg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DMG Digital Enterprises Se | Hamburg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DMP Dental Industry S.A. | Markopoulo Attiki, Greece | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dreve Dentamid GMBH | UNNA North Rhine-Westphalia, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DXM Co., Ltd. | Jeonnam-Gwangju Special Metropolitan City, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Elite Dental Lab | Huizhou City Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Enlighten Materials Co., Ltd. | Taipei City, Taiwan | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fricke Dental MFG. Co. | Streamwood, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Formlabs Inc. | Somerville, MA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Formlabs Ohio, Inc. | Millbury, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Garish Apparels | Wazirabad Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GC America Inc. | Alsip, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Heygears Imc.inc | Guangzhou Guangdong, China | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guilin Kevin Peter Technology Co., Ltd. | Guilin Guangxi, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hager Worldwide, Inc. | Hickory, NC, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Handae Chemical Co., Ltd | Jincheon-gun Chungbuk, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Shining3d Dental Technology Co., Ltd | Hangzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hdi Inc. | Seongnam-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ho Chi Minh Branch - Vatech Viet Joint Stock Company | Thanh My Tay Ward Ho Chi Minh, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Huaian Tisurg Medical Instruments Co., Ltd. | Huaian City Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hubei Guarddent Medical Technology Co.,ltd | Wuhan Hubei, China | 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 | |
| Imicryl Dis Malzemeleri Sanayi Ve Ticaret A.S. | Konya, Turkey | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Improve Co.,limited | Lantau Island Hong Kong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Innovation Meditech GMBH | UNNA North Rhine-Westphalia, Germany | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ivoclar Vivadent AG | Schaan, Liechtenstein | Contract manufacturer, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ivoclar Vivadent Manufacturing GmbH | NATURNO (BZ) Bolzano, Italy | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jamesb Dental Studio | Dumont, NJ, United States | 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 | |
| Kettenbach GMBH & Co KG | ESCHENBURG Hesse, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Keystone Industries | Myerstown, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Keystone Industries | Cherry Hill, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Keystone Industries - Gibbstown | Gibbstown, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lang Dental MFG. Co., Inc. | Wheeling, IL, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Laparomed Private Limited | Mumbai Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Liaoning Xinaite Technology Co.,ltd | benxi Liaoning, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lohar Medical Company | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Loyol New Material Suhzou Co.,Ltd. | Suzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Major Prodotti Dentari S.P.A. | MONCALIERI Torino, Italy | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Maquira Industria De Produtos Odontologicos | Maringa Parana, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medcave Private Limited | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Megadenta Dentalprodukte GMBH | RADEBERG Saxony, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Merz Dental GMBH | LUETJENBURG Schleswig-Holstein, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda. | SAO CARLOS Sao Paulo, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Monitex Industrial Co., Ltd. | SAN-CHUNG CITY Taipei, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mount Blonck Trading | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nadir & Co. | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nanjing Chamlion Laser Technology Co., Ltd. | Nanjing Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nanova Biomaterials Inc | Columbia, MO, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| New Stetic | GUARNE Antioquia, Colombia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nucare LLC | Montclair, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| One Day Dental Partner | Suncheon-si Jeonnam, South Korea | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orthguide Medical Technology (jiangsu) Co., Ltd | Wuxi City Jiangsu, China | Contract manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pac-Dent Inc. | Brea, CA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pacific Care Limited / Pacificare Asia Limited | Hong Kong, Hong Kong | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Panorama International. | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Perflex Ltd | Netanya Central, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips Oral Healthcare, LLC | Bothell, WA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Plasdent Shanghai Co., Ltd. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PNUAdd Co., Ltd. | Busan, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Prime Dental Manufacturing, Inc. | Chicago, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pro3dure Medical GMBH | Iserlohn North Rhine-Westphalia, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pulpdent Corporation | Watertown, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Power Dental USA, Inc. | McHenry, IL, United States | Manufacturer, Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ray Co., Ltd | Yongin-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Renewmedical Co., Ltd. | Bucheon-si, Gyeonggi-do, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Richbolt Enterprises | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Riton 3D Technology Co., Ltd | Guangzhou Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| S & C Polymer GMBH | ELMSHORN Schleswig-Holstein, Germany | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sabri Industries | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scientific Pharmaceuticals, Inc. | Pomona, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Seilglobal Co., Ltd | Busan Gyeongnam, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Lions Industrial Co.,ltd. | Shanghai, China | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shengiho Enterprise Co., Ltd. | Taichung City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Jinyi Medical Technology Co.,ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Moye Technology Co Ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Piocreat 3D Technology Co., Ltd | Shenzhen Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Yongchanghe Technology Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Signor Seven International | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SMD Dental Laboratory | Heungdeok-gu Cheongju-si Chungbuk, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smilden Biotechnology Co., Ltd. | New Taipei City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Spident Co., Ltd. | INCHEON Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sprintray Inc. | Los Angeles, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sprintray Inc. | Huntington Beach, CA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Laixin 3D Technology Co.,ltd | Suzhou Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Saga Dental Supply AS | Kongsvinger Hedmark, Norway | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shandong Huge Dental Material Corporation | Rizhao Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Coherz Technologies Co., Ltd. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai, China | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov | |
| Solventum Germany GmbH | Kamen North Rhine-Westphalia, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Solventum Orthodontics Corporation | Monrovia, CA, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sterngold Dental LLC | Attleboro, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Pac-Dent Technology Co., Ltd | SUZHOU CITY Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tangshan Zhengtong Exhibition Co., Ltd. | Tangshan Hebei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| TC Dental & Medical Supplies, Inc. | Anaheim, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tianjin Water Source Tech Co., Ltd. | Tianjin, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| TP Orthodontics, Inc. | La Porte, IN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| The Belport Company, Inc DBA Gingi-Pak | Camarillo, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Union Dental S.A. | TIELMES Madrid(Province), Spain | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ustomed Instrumente GMBH & Co. KG | Tuttlingen Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ultradent Products Inc. | South Jordan, UT, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vericom Co., Ltd. | Chuncheon-Si Gangwon, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vertex-Dental B.V. | Soesterberg Utrecht, Netherlands | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Voco GMBH | CUXHAVEN Lower Saxony, Germany | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vedia Solutions, Division of Laxmi Dental Limited | Palghar Maharashtra, India | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Whip-Mix Corp. | Louisville, KY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wright Health Group | Dundee Dundee City, United Kingdom | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Weldon Instruments | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiamen Antinsky Industry Co., Ltd | Xiamen Fujian, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiamen Zhiyuan Medical Technology Co., Ltd. | XIAMEN Fujian, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yamahachi Dental MFG. Co. | Gamagori City Aichi, Japan | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yamahachi Dental Material (Changshu) Co., Ltd. | Changshu city Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhengzhou Huaer Electro-Optics Technology Co., Ltd. | Zhengzhou Henan, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zirkonzahn SRL | Gais Bolzano, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ziyang Rayform Technology Co., Ltd | Ziyang City Sichuan, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ZOGEAR Medical Co., Ltd. | Yizheng Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.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.