Data / Medical devices / Accessories, Retractor, Dental
Accessories, Retractor, Dental (EIF): 128 FDA-registered makers in 22 countries
128 establishments in 22 countries are registered with the FDA to make Accessories, Retractor, Dental (product code EIF, Class 1, 21 CFR 872.4565). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 4 510(k) clearances under this code, the latest on October 5, 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
- EIF
- Device class
- 1
- Regulation
- 872.4565
- Medical specialty
- Dental
Makers by country
| Country | Makers |
|---|---|
| China | 34 |
| United States | 30 |
| Pakistan | 22 |
| South Korea | 9 |
| Germany | 6 |
| Switzerland | 4 |
| France | 3 |
| Italy | 3 |
| Mexico | 2 |
| Sweden | 2 |
| Finland | 2 |
| Japan | 1 |
| Ireland | 1 |
| Liechtenstein | 1 |
| Brazil | 1 |
| India | 1 |
| Taiwan | 1 |
| United Kingdom | 1 |
| Hungary | 1 |
| Norway | 1 |
| Russia | 1 |
| Malaysia | 1 |
Makers of Accessories, Retractor, Dental
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 |
|---|---|---|---|---|---|---|---|---|
| Accompany Surgical | SIALKOT Punjab, Pakistan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aesculap AG | TUTTLINGEN, DONAU Baden-Wurttemberg, Germany | 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 | |
| Armor Dental Corp | Hingham, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ascentcare Dental Products | Grand Haven, MI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ATRIA Co. | Seoul, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Align Technology, Inc. | San Jose, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aligntech de Mexico S, de R. L. de C. V. | Cd. Juarez Chihuahua, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aligntech de Mexico S, de R. L. de C. V. | Cd. Juarez Chihuahua, Mexico | 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 | |
| Bing Innovations LLC | Boca Raton, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomet Microfixation | Jacksonville, FL, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boen Healthcare Co., Ltd. | Suzhou Jiangsu, China | Exporter to the US, Specification developer | 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 | |
| Changzhou Shengkang Medical Instrument Co.,ltd | Changzhou Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Coltene/Whaledent AG | ALTSTAETTEN Sankt Gallen, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Comfort Surgical Instruments | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Commic Surgico | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Confident Instruments | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Crown Surgical Corp. | Sialkot Punjab, Pakistan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CranioMandibular Rehab, Inc. | Wheat Ridge, CO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DCI International, LLC | Newberg, OR, United States | 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 | |
| Denjoy Dental Co., Ltd | Changsha city Hunan, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Denta Craft Instruments | Sialkot Punjab, Pakistan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dental Monitoring | PARIS Ile-de-France, France | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dental Studio | Anyang-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentalmaster (xiamen) Medical Technology Co., Ltd. | Xiamen Fujian, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentatus AB | SPANGA Stockholm, Sweden | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentech Corp. | Tokyo, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentis Co., Ltd. | Daegu, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentozone Corporation | Guro-gu Seoul, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DIO Corporation | Haeundae-gu Busan, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Yilong Medical Supplies Co.. Ltd. | Dongguan Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| E.M.S. Electro Medical Systems S.A. | NYON Vaud, Switzerland | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eldo S.R.L | Vallesaccarda Campania, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Forefront (xiamen) Medical Devices Co., Ltd. | Xiamen Fujian, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Falcon Surgical Co. (Pvt.) Ltd. | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fomed Industries Inc | Qian Jiang Hubei, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Garish Apparels | Wazirabad Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GARNET DENTECH Corp | Daegu, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gate Dental Services Ltd | Galway Galway(County), Ireland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GC Orthodontics America Inc. | Alsip, IL, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gestenco International AB | GOTEBORG Vastra Gotaland, Sweden | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Glorious Mercantile Corp. (pvt) Ltd. | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Great Lakes Dental Technologies, Ltd. | Tonawanda, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangdong Xinuo Personal Care Products Co., Ltd | Yunfu City Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| H & H Co. | Hayden, ID, United States | Contract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hager & Werken GMBH | DUISBURG,DE-NOTA Hamburg, Germany | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Chohotech Co., Ltd | Hangzhou Zhejiang, China | 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 | |
| Hexamed Pvt Ltd | Sialkot Punjab, Pakistan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hilbro Instruments (pvt) Ltd. | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hilbro International (pvt) Limited | SIALKOT Punjab, Pakistan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hospimed MFG | Sialkot Punjab, Pakistan | 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 | |
| Inion OY | TAMPERE Pirkanmaa, Finland | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| IPB Inc | Ogden, UT, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ivoclar Vivadent AG | Schaan, Liechtenstein | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| J & J Instruments, LLC | Northbrook, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| J. Morita Usa, Inc. | Irvine, CA, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jay-Med | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| JJGC Industria e Comercio de Materiais Dentarios SA | Curitiba Parana, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kohler Medizintechnik GmbH | STOCKACH Baden-Wurttemberg, Germany | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lacigrus International | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Leone SPA | Sesto Fiorentino Firenze, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Libral Traders Pvt. Ltd. | New Delhi, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mectalent Ltd. | Oulu Kainuu, Finland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medcave Private Limited | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MEDESY srl | MANIAGO Pordenone, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nichrominox | SAINT BONNET DE MURE Rhone, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Aolbea Oral Care Products Co., Ltd | Yuyao City Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| North Eos Industries, Inc. | Taichung City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nucare LLC | Montclair, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nova Instruments | Berkshire Wokingham, United Kingdom | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orthopli Corp. | Philadelphia, PA, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Osstem Implant Co., Ltd. | Gangseo-gu Seoul, South Korea | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Osstem Implant Co., Ltd. | Haeundae-gu Busan, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ortho Solutions LC | Lake Saint Louis, MO, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips Oral Healthcare, LLC | Bothell, WA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Phoenix Instruments, Inc. | Lisle, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Plastics Plus Technology, Inc. | Redlands, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Practicon, Inc. | Greenville, NC, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Prodont-Holliger S.A.S. | OLLIERGUES Puy-de-Dome, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pascal International, Inc. | Bellevue, WA, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Perfect Group Corp. Ltd. | yangzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quality Aspirators, Inc. | Dallas, TX, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quality Aspirators, Inc. | Duncanville, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quality Concept (pvt) Ltd. | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ready Set Import | Beverly Hills, CA, United States | 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 | |
| SFS Group Hungary KFT. | Janossomorja Gyor-Moson-Sopron, Hungary | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SFS Group Schweiz AG, KUNSTSTOFFWERK | Altstaetten Sankt Gallen, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SGS Export Intl. | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shandong Zhushi Pharmaceutical Group Co., Ltd | Heze Shandong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Alwings Medical Instrument Co.,ltd. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Denco Medical Co., Ltd. | Shenzhen Guangdong, China | Contract manufacturer, Exporter to the US, 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 | |
| Sinntech Medical (private) Limited | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smile Line SA | St-Imier Bern, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sobytek Instruments Co. | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Solventum Us LLC | Eagan, MN, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sonendo, Inc. | Laguna Hills, CA, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stone Instruments Co. | SIALKOT Punjab, Pakistan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Storz Am Mark GMBH | EMMINGEN-LIPTINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sure Dent Corporation | SEONGNAM-SI Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Saga Dental Supply AS | Kongsvinger Hedmark, Norway | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sanbor Medical Xiamen, Inc. | Xiamen Fujian, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Senlede Technologies Co., Ltd | Shenzhen Guangdong, China | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov | |
| Solventum US LLC | Irvine, CA, United States | Manufacturer, Repackager or relabeler | 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 | |
| Taizhou Rich Medical Products Co., Ltd. | TAIZHOU Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Technimen Skillers | SIALKOT Punjab, Pakistan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tontarra Medizintechnik GMBH | WURMLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tor VM Ltd. | Moscow Moskva, Russia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| TP Orthodontics, Inc. | La Porte, IN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Unip Plastic Industries Sdn Bhd | CHERAS Selangor, Malaysia | Contract 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 | |
| Xiantao S&J Protective Products Co., Ltd | Xiantao Hubei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xinhua Surgical Instrument Co. Ltd. | ZIBO Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Jasmine Oralcare Products Co., Ltd. | Jiaxing Zhejiang, China | Contract manufacturer, Exporter to the US, 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 | |
| ZOGEAR Medical Co., Ltd. | Yizheng Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zyris, Inc. | Santa Barbara, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| iBrite Suzhou Technology Co., Ltd | SUZHOU CITY Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 5, 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.