Data / Medical devices / Handle, Instrument, Dental
Handle, Instrument, Dental (EJB): 213 FDA-registered makers in 23 countries
213 establishments in 23 countries are registered with the FDA to make Handle, Instrument, Dental (product code EJB, Class 1, 21 CFR 872.4565). 2 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 8 510(k) clearances under this code, the latest on July 8, 2014, and lists 1 recall event (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
- EJB
- Device class
- 1
- Regulation
- 872.4565
- Medical specialty
- Dental
Makers by country
| Country | Makers |
|---|---|
| Pakistan | 59 |
| United States | 47 |
| China | 28 |
| Germany | 17 |
| South Korea | 13 |
| Italy | 6 |
| Brazil | 5 |
| Switzerland | 4 |
| Sweden | 4 |
| Israel | 3 |
| Taiwan | 3 |
| France | 3 |
| India | 3 |
| Malaysia | 3 |
| United Kingdom | 3 |
| Spain | 2 |
| Denmark | 2 |
| Japan | 2 |
| Russia | 2 |
| Australia | 1 |
| Finland | 1 |
| Canada | 1 |
| Hong Kong | 1 |
Makers of Handle, Instrument, 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 |
|---|---|---|---|---|---|---|---|---|
| Centrix, Inc. | Shelton, CT, United States | Contract manufacturer, Manufacturer | 1 | July 8, 2014 | 0 | 0 | 0 | api.fda.gov |
| Garrison Dental Solutions | Spring Lake, MI, United States | Complaint file establishment, Specification developer | 1 | July 8, 2014 | 0 | 0 | 0 | api.fda.gov |
| A Fone Surgico | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| A. Schweickhardt GMBH & Co. KG | Seitingen-Oberflacht Baden-Wurttemberg, Germany | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| A.B. Dental Devices Ltd | Ashdod Southern, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Accompany Surgical | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Acheron Instruments (pvt.) Ltd. | LAHORE Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Acme Enterprises | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aditek Do Brasil, SA | CRAVINHOS Sao Paulo, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aesculap AG | TUTTLINGEN, DONAU Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alliance Global Technology Co., Ltd. | Kaohsiung, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ALVI Expo | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Amedcon Medical Technology (shenzhen) Co., Ltd. | Shenzhen Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| American Eagle Instruments | Missoula, MT, United States | 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 | |
| Anthogyr | SALLANCHES Haute-Savoie, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Armatech International | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aseptico, Inc. | Woodinville, WA, United States | Complaint file establishment, Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ATRIA Co. | Seoul, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Allied Medical LLC | Earth City, MO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Autocam Medical | Murfreesboro, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Auxein medical Private limited | Sonipat Haryana, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| B&L Biotech Co., Inc | Ansan City Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| B. Ali Impex | SIALKOT, Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| B. Braun Medical Industries Sdn. Bhd. | PENANG Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| B.T.I. Biotechnology Institute, S.L. | Miñano Alava, Spain | Exporter to the US, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bashir Jamil & Brothers (pvt.), Ltd. | Sialkot Punjab, Pakistan | 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 | |
| Biomaterials Korea Inc. | Hanam-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomet Microfixation | Jacksonville, FL, United States | Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Brasseler U.S.A. Dental, LLC | Savannah, GA, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bailey Instruments Ltd | Manchester, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Basic Dental Implant Systems, Inc. | Rio Rancho, NM, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bioclear Matrix Systems, LLC | Tacoma, WA, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biopsy Fine Cut Instruments | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Central Surgical Co. Pvt. Ltd. | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Choose Surgical Instruments | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Chung Song Industrial Co. | YONGIN-SI Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Coda Resources Ltd., Heze China | Heze, Shandong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Coltene/Whaledent Inc. | Cuyahoga Falls, OH, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Comfort Surgical Instruments | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Concise Enterprises | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Confident Instruments | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Contech Holdings LLC | Brea, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Creative Dental Concepts LLC | Birmingham, MI, United States | 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 | |
| Curaden AG | Kriens Luzern, Switzerland | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changsha Easyinsmile Intelligence Technology Co.Ltd. | Changsha Hunan, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cislak Manufacturing, Inc. | Niles, IL, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Complexus Medical | Mishawaka, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| D B Orthodontics Ltd | WEST YORKSHIRE England, United Kingdom | Complaint file establishment, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Daddy D Pro | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Daekwang I.D.M | Seoul, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Darleys Surgical Co. | Sialkot, Punjab, Pakistan | 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 | |
| Den Tag S.R.L. | MANIAGO, PN. Pordenone, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Densol International (private) Limited | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dent4you AG | Heerbrugg Sankt Gallen, Switzerland | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Denta Craft Instruments | Sialkot Punjab, Pakistan | 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 | |
| Devemed GMBH | NEUHAUSEN OB ECK Baden-Wurttemberg, Germany | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Directa AB | UPPLANDS VAESBY Stockholm, Sweden | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentaurum GmbH & Co. KG | ISPRINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| E. Hahnenkratt GMBH | KOENIGSBACH-STEIN Baden-Wurttemberg, Germany | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Empire Surgical Instruments Company | Sialkot Punjab, Pakistan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Erchinger AG | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ergodenta Aps | Taastrup Hovedstaden, Denmark | Contract manufacturer, Manufacturer, Repackager or relabeler | 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 | |
| Essential Dental Systems, Inc. | S Hackensack, NJ, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Evidence Implant Inc. | Daegu, South Korea | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Forward Science Technologies LLC | Houston, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Falcon Surgical Co. (Pvt.) Ltd. | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| G.A. Surgical (pvt) Ltd. | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Garish Apparels | Wazirabad Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GC Dental Products Corp. | KASUGAI-SHI Aichi, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Glorious Mercantile Corp. (pvt) Ltd. | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Goldman Products, Inc. | Wauconda, IL, United States | Contract manufacturer, Manufacturer, Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GoldenDent | Roseville, MI, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hazel Enterprises | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hefei Mlush Sanitary Products Co.,ltd | Hefei Anhui, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Helmut Zepf Medizintechnik GMBH | SEITINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Herd Star Company, Inc. | Dauphin, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HGR Instrumente GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hilbro Instruments (pvt) Ltd. | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hospimed MFG | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hu-Friedy MFG Co., LLC | Des Plaines, IL, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hu-Friedy MFG. Co. LLC | Northbrook, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Implant Protesis Dental 2004, S.L. | Premia de Dalt Barcelona, Spain | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Indusbello Industria De Instrumentos Odo | Londrina Parana, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Industria Zingardi S.R.L | Novi Ligure Piedmont, Italy | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Infirmary Medical Supplies | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Innobiosurg Co., Ltd. | Daejeon, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Instrumental Machine & Development, Inc. | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Instrumed International Inc dba Avalign German Specialty Instruments | Schaumburg, IL, United States | Contract manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Integra LifeSciences Production Corporation | Mansfield, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Itena Clinical Villepinte | Villepinte Seine-Saint-Denis, France | 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 | |
| Jay-Med | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangmen Zhi Qu Metal Plastic Industrial Co., Ltd. | Jiangmen, Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jinyuan Medical Equipment(tianjin)co.,ltd | Tianjin, China | 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 | |
| Kazan Medical Instruments Plant Joint Stock Compan | KAZAN Tatarstan, Russia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| KLS Martin Se & Co. KG | Fridingen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| KLS Martin Malaysia Sdn. Bhd. | Simpang Ampat Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| KLS Martin SE & Co. KG | Muhlheim/Donau Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| KLS-Martin L.P. | Jacksonville, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Keystone Dental Inc. | Irvine, CA, United States | 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 | |
| La.sc.od. SPA | FLORENCE, TUSCANY Firenze, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lacigrus International | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lm-Instruments OY | PARAINEN Varsinais-Suomi, Finland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Madina Surgical Works | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Maillefer Instruments Holding Sarl | BALLAIGUES Vaud, Switzerland | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MC Bio S.R.L. | Lomazzo Como, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mctbio | Yongin-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medcave Private Limited | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Systems And Devices International Ltd. | Kiryat Ata Haifa, Israel | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medisporex (pvt) Ltd. | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Meed Skills Surgical | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Melpex Beauty Instruments | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Metro Medical | Sialkot Punjab, Pakistan | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mian Shahid Corp. | MUZAFFAR PUR, SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Micerium S.P.A. | AVEGNO Genova, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Miing Wei Co., Ltd. | Tsao-Twon Nantou, 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 | |
| Nawaz And Sons | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Neoss AB | Goteborg Vastra Gotaland, Sweden | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nextcon International | Sialkot Punjab, Pakistan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nobil-Metal S P A | Villafranca Dasti, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nordent MFG., Inc. | Elk Grove Village, IL, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| NR Surgical Company | Sialkot Punjab, Pakistan | 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 | |
| Oertel Medical GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Onvet Medical Canada Inc | TORONTO Ontario, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ortho Organizers, Inc. | Savannah, GA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orthopli Corp. | Philadelphia, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ossvis Co., Ltd. | Anyang-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Osteogenics Biomedical, Inc. | Lubbock, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Osung MND Co., Ltd. | Gimpo-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ot Medical GMBH | Bremen, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Otto Leibinger GMBH | MUEHLHEIM Baden-Wurttemberg, Germany | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orchid Orthopedic Solutions Alabama LLC | Arab, AL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paltop Advanced Dental Solutions Ltd | Caesarea Central, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Panorama International. | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PDT, Inc. | Msla, MT, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Phoenix Instruments, Inc. | Lisle, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pilotis Tech LLC | Brookhaven, GA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Premier Dental Products Co. | Plymouth Meeting, PA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Premier Medical | Philadelphia, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Premium Plus (dongguan) Limited | Dongguan Guangdong, China | Manufacturer | 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 | |
| Pru-Dent MFG., Inc. | Schaumburg, IL, United States | Manufacturer, Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| PSM Medical GmbH | Gunningen Baden-Wurttemberg, Germany | 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 | |
| Premium Plus International Limited | Hong Kong, Hong Kong | 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 | |
| Ronvig Dental MFG. A/S | DAUGAARD Midtjylland, Denmark | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sabokay Industries | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Saeshin Precision Co., Ltd. | Daegu, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sanctuary Health Sdn Bhd | Chemor Perak, Malaysia | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Schobell Industrial Ltda | Rio Claro Sao Paulo, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Fanta Dental Materials Co., Ltd. | Shanghai, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Medical Instruments (group) Ltd. Corp. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanwei Perfect Medical Instruments Co.,ltd. | Shanwei Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shengiho Enterprise Co., Ltd. | Taichung City, Taiwan | 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 Perfect Medical Instruments Co., Ltd. | Shenzhen Guangdong, China | 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 | |
| Shurcon Manufacturing Company | Jia Shan Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Silver Plus Corp. | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sinntech Medical (private) Limited | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Spartech Instruments & Co. | Sialkot, Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Specialized Care Co Inc | Hampton, NH, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Speedway | India Delhi, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Storz Am Mark GMBH | EMMINGEN-LIPTINGEN Baden-Wurttemberg, Germany | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Surgicrafts | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Surgikare | SIALKOT Punjab, Pakistan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Surgiscape | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Ramo Medical Instrument Co., Ltd. | Suzhou City Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Svenska Dentorama AB | SOLLENTUNA Stockholm, Sweden | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Swengg Co | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Symmetry Medical Manufacturing Inc | Claypool, IN, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Symmetry Medical Manufacturing Inc. | Warsaw, IN, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Meijiante Technology Co., Ltd | Shenzhen Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shinhung MST Co., Ltd. | Wonju Si Gangwon, South Korea | 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 | |
| T.A. Walthem & Company | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tangshan Zhengtong Exhibition Co., Ltd. | Tangshan Hebei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| TDV Dental Ltda | POMERODE Santa Catarina, Brazil | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Technimen Skillers | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| TF New Material Sci And Tec Co.,ltd | Huainan Anhui, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Thommen Medical, AG | GRENCHEN Solothurn, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tor VM Ltd. | Moscow Moskva, Russia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Towne Brothers (pvt.), Ltd. | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tribest Dental Products Co Ltd | Yangzhong Jiangsu, China | Exporter to the US, 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 | |
| Vericom Co., Ltd. | Chuncheon-Si Gangwon, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Washington Surgical International | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Winning Appliance Manufactory Limited | CHAI WAN HONG KONG Xinjiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wise Instruments | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xinhua Surgical Instrument Co. Ltd. | ZIBO Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Y. Z. Corporation | SIALKOT Punjab, Pakistan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ydm Corporation | HIGASHIMATSUYAMA-SHI Saitama, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Young Microbrush LLC | Grafton, WI, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zain's Medical Image | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zentro Enterprise Pvt Ltd | RAJKOT Gujarat, India | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zirc Dental Products, Inc. | Buffalo, MN, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ZOGEAR Medical Co., Ltd. | Yizheng Jiangsu, China | 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 July 8, 2014. 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.