Data / Medical devices / Wax, Dental, Intraoral
Wax, Dental, Intraoral (EGD): 136 FDA-registered makers in 24 countries
136 establishments in 24 countries are registered with the FDA to make Wax, Dental, Intraoral (product code EGD, Class 1, 21 CFR 872.6890). 2 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 25 510(k) clearances under this code, the latest on February 11, 2002, 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
- EGD
- Device class
- 1
- Regulation
- 872.6890
- Medical specialty
- Dental
Makers by country
| Country | Makers |
|---|---|
| China | 48 |
| United States | 37 |
| Germany | 9 |
| South Korea | 5 |
| Pakistan | 4 |
| Mexico | 4 |
| Japan | 4 |
| India | 3 |
| United Kingdom | 2 |
| Switzerland | 2 |
| Taiwan | 2 |
| Brazil | 2 |
| Italy | 2 |
| Colombia | 2 |
| United Arab Emirates | 1 |
| Turkey | 1 |
| Dominican Republic | 1 |
| Canada | 1 |
| Netherlands | 1 |
| Hong Kong | 1 |
| Vietnam | 1 |
| Australia | 1 |
| Belgium | 1 |
| Spain | 1 |
Makers of Wax, Dental, Intraoral
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 |
|---|---|---|---|---|---|---|---|---|
| Garreco, LLC | Heber Springs, AR, United States | Manufacturer | 7 | August 21, 1991 | 0 | 0 | 0 | api.fda.gov |
| Kulzer, LLC | South Bend, IN, United States | Contract manufacturer, Manufacturer | 2 | November 17, 1992 | 0 | 0 | 0 | api.fda.gov |
| Accompany Surgical | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Advanced Dental Designs | Moreno Valley, CA, United States | 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 | |
| American Orthodontics | Sheboygan, WI, United States | Manufacturer, Repackager or relabeler | 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 | |
| Arak Dental Lab | Sharjah Dubayy, United Arab Emirates | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Asap LLC | Santa Fe Spgs, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ashtel Studios, Inc. | Ontario, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Associated Dental Products Ltd | Swindon Wiltshire, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ATRIA Co. | Seoul, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aadi Med Private Limited | Dist. Palghar Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bilkim Ltd Co. | Izmir, Turkey | Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bisco, Inc. | Schaumburg, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bredent GMBH & Co.kg | SENDEN Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Calibaja Manufacturing, S.A. De C.V. | MEXICALI Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Candulor, AG | Glattpark Zurich, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cangzhou Lankang Medical Instruments Developing Co., Ltd. | Cangzhou Hebei, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Caribbean Custom Mold Inc | Santo Domingo, Dominican Republic | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Carmel Industries | Montreal Quebec, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cavex Holland B.V. | HAARLEM Noord-Holland, Netherlands | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changshu Shangchi Dental Materials Co., Ltd. | Changshu Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Chewink Corp. | New Taipei City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Coltene/Whaledent Inc. | Cuyahoga Falls, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Coral Healthcare Products Manufacturer Co., Ltd. | YANGZHOU 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 | |
| DENKEN-HIGHDENTAL Co., Ltd. | Kyoto, Japan | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Denta Craft Instruments | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DENTACO GmbH & Co. KG | Essen North Rhine-Westphalia, Germany | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dental Morelli Ltda. | SOROCABA Sao Paulo, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentos, Incorporated | Daegu, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Digital Dental Depot | zhuhai Guangdong, China | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Digital Dental Depot Limited | Hong Kong, Hong Kong | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DIO Corporation | Haeundae-gu Busan, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DenTek Oral Care, Inc. | Tarrytown, NY, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentaurum GmbH & Co. KG | ISPRINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Digital Age Dental Laboratories, Ltd. | Vinh Tan Ward Ho Chi Minh, Vietnam | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dr. Jean Bausch GmbH & Co. KG | COLOGNE North Rhine-Westphalia, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Endo Tech Instruments | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Erskine Dental | MACKSVILLE New South Wales, Australia | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Elemental NV | Ghent Oost-Vlaanderen, Belgium | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Freeman Manufacturing & Supply Co. | Avon, OH, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GC Corp. | ITABASHI-KU Tokyo, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GC Orthodontics America Inc. | Alsip, IL, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gebdi Dental Products GMBH | Engen Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Cheer-U Material Technology Co., Ltd | Guangzhou Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gurunanda LLC | Buena Park, CA, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Great Lakes Dental Technologies, Ltd. | Tonawanda, NY, United States | Specification developer | 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 | |
| Hangzhou Pengwu Medical Equipment Co.,ltd | Hangzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Wise Medical Device Co.,ltd | Hangzhou Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Henan Baistra Medical Devices Limited | Zhengzhou Henan, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Huanghua DK Dental Co., Ltd | HuangHua Hebei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Huanghua Promisee Dental Co., Ltd | Huanghua Hebei, 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 | |
| Hunan Vsmile Biotechnology Co.,ltd | Changsha Hunan, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Huliang (shanghai) Bio-Tech Co., Ltd. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Integra LifeSciences Production Corporation | Mansfield, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ivoclar Vivadent Manufacturing, Inc | Somerset, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| J-Energy Daily Care Products Co.,ltd | Yangzhou Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Bailu Brushes Co., Ltd | YANGZHOU Jiangsu, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Province Yangzhou Shuguang Toothbrush Manufactory | YANG ZHOU Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiscop Co., Ltd. | Gunpo-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kent Manufacturing Company | Grand Rapids, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kerr Corporation | Pomona, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Keystone Industries | Myerstown, PA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Leone SPA | Sesto Fiorentino Firenze, Italy | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Libral Traders Pvt. Ltd. | New Delhi, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Manufacturera Dental Continental | ZAPOPAN Jalisco, Mexico | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Maquira Industria De Produtos Odontologicos | Maringa Parana, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mediclus Co., Ltd | Cheongju-si Chungbuk, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtech Products, Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Memphis Dental MFG. Co., Inc. | Memphis, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Merz Dental GMBH | LUETJENBURG Schleswig-Holstein, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Natural Esthetics | Fuessen Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| New Phenix Home Products Manufactory Co., Ltd. | YANGZHOU Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| New Stetic | GUARNE Antioquia, Colombia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nimi Chemical Industrial Co., Ltd. | Kiryu Gunma, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Haishu Zonghai Artware Co., Ltd. | Ningbo City Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| O&S Dental, Inc. | Chicago, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ortho Organizers, Inc. | Savannah, GA, United States | Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orvance, LLC | Caledonia, MI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ormco Corporation | Brea, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pac-Dent Inc. | Brea, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pesitro Healthcare Products Co., Ltd. | Yangzhou Jiangsu, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Placecol S.A | funza Cundinamarca, Colombia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Prevest Denpro Limited | Jammu Jammu and Kashmir, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Prime Dental Manufacturing, Inc. | Chicago, IL, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Qingdao Jinpuguangyuan Science And Technology Co.,ltd | Qingdao Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ranir LLC | Grand Rapids, MI, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Reko Dental, LLC | Gardena, CA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Reliance Orthodontic Products, Inc. | Itasca, IL, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rosemarie Products Company, LLC | Mason, OH, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ranir Changshu Oral Care CO., Ltd | Changshu Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sagemax Bioceramics, Inc. | Federal Way, WA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scanderra LLB AG | Basel Basel-Stadt, Switzerland | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shandong Hengfeng Kerui Medical Equipment Co., Ltd | Qingdao City Shandong, China | Contract manufacturer, Exporter to the US, 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 | |
| Shen Fu Arts Lab | Shen Zhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Denco Medical Co., Ltd. | Shenzhen Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Rogin Medical Co., Ltd | shenzhen Guangdong, China | Contract manufacturer, 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 | |
| Shenzhen Yuechuan Trade Co., Ltd. | shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shumei Industrial (hebei) Co., Ltd. | Cangzhou Hebei, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Signor Seven International | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ST. George Technology, Inc. | Wilmington, NC, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sunstar Americas, Inc. | Schaumburg, IL, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shandong Huge Dental Material Corporation | Rizhao Shandong, 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 | |
| Sharp Detail Orthodontic Laboratory S DE EL DE CV | Tijuana Baja California, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Golden Wish Personal Care Co.,Ltd | Shenzhen Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Sunmc Dental Technology Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shummi Enterprise Co., Ltd. | Taipei, Taiwan | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Solventum Orthodontics Corporation | Monrovia, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sonrisa/Easy Denture/NSI | Wilmington, NC, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Union Dental S.A. | TIELMES Madrid(Province), Spain | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ultradent Products Inc. | South Jordan, UT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vago International Manufacturing SA De CV | Monterrey Nuevo Leon, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vita Zahnfabrik H. Rauter GMBH & Co. KG. | BAD SACKINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Weihai Jieshi Commodity Manufacture Co. Ltd. | Weihai,Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wright Health Group | Dundee Dundee City, United Kingdom | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wuhu Guli Ortho Co.,ltd | Wuhu Anhui, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wellmed Dental Medical Supply Co., Ltd | Shenzhen Guangdong, China | 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 | |
| Yamahachi Dental MFG. Co. | Gamagori City Aichi, Japan | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yangzhou Chenxiao Brush Industrial Co., Ltd. | YANGZHOU Jiangsu, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yangzhou Royal Home Products Manufacture Co., Ltd. | Yangzhou Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yeti Dentalprodukte GMBH | Engen Baden-Wurttemberg, Germany | Manufacturer, Specification developer | 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 | |
| Yangzhou Yichuan Plastic Technology Co., Ltd. | Yangzhou City Jiangsu, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Jasmine Oralcare Products Co., Ltd. | Jiaxing Zhejiang, China | Contract manufacturer, Foreign private label distributor, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Mediunion Healthcare Group Co.,ltd | Ningbo Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Yamei Medical Equipment Technology Co., Ltd. | Yang Jiao Lang Zin'an Town Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zirkonzahn SRL | Gais Bolzano, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ZOGEAR Medical Co., Ltd. | Yizheng Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated February 11, 2002. 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.