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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

CountryMakers
China34
United States30
Pakistan22
South Korea9
Germany6
Switzerland4
France3
Italy3
Mexico2
Sweden2
Finland2
Japan1
Ireland1
Liechtenstein1
Brazil1
India1
Taiwan1
United Kingdom1
Hungary1
Norway1
Russia1
Malaysia1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Accompany SurgicalSIALKOT Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
Aesculap AGTUTTLINGEN, DONAU Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Anqing Clean Dental Instrument Technology Co.,ltdAnqing City Anhui, ChinaExporter to the US, Manufacturer0000api.fda.gov
Armor Dental CorpHingham, MA, United StatesManufacturer0000api.fda.gov
Ascentcare Dental ProductsGrand Haven, MI, United StatesManufacturer0000api.fda.gov
ATRIA Co.Seoul, South KoreaManufacturer0000api.fda.gov
Align Technology, Inc.San Jose, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Aligntech de Mexico S, de R. L. de C. V.Cd. Juarez Chihuahua, MexicoManufacturer0000api.fda.gov
Aligntech de Mexico S, de R. L. de C. V.Cd. Juarez Chihuahua, MexicoManufacturer0000api.fda.gov
BH Medical Products Co., LtdChangzhou City Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Bing Innovations LLCBoca Raton, FL, United StatesManufacturer0000api.fda.gov
Biomet MicrofixationJacksonville, FL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Boen Healthcare Co., Ltd.Suzhou Jiangsu, ChinaExporter to the US, Specification developer0000api.fda.gov
Cangzhou Lankang Medical Instruments Developing Co., Ltd.Cangzhou Hebei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Changzhou Shengkang Medical Instrument Co.,ltdChangzhou Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Coltene/Whaledent AGALTSTAETTEN Sankt Gallen, SwitzerlandManufacturer0000api.fda.gov
Comfort Surgical InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Commic SurgicoSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Confident InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Crown Surgical Corp.Sialkot Punjab, PakistanExporter to the US, Manufacturer0000api.fda.gov
CranioMandibular Rehab, Inc.Wheat Ridge, CO, United StatesManufacturer0000api.fda.gov
DCI International, LLCNewberg, OR, United StatesManufacturer0000api.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
Denjoy Dental Co., LtdChangsha city Hunan, ChinaManufacturer0000api.fda.gov
Denta Craft InstrumentsSialkot Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
Dental MonitoringPARIS Ile-de-France, FranceComplaint file establishment, Manufacturer0000api.fda.gov
Dental StudioAnyang-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Dentalmaster (xiamen) Medical Technology Co., Ltd.Xiamen Fujian, ChinaManufacturer0000api.fda.gov
Dentatus ABSPANGA Stockholm, SwedenManufacturer0000api.fda.gov
Dentech Corp.Tokyo, JapanManufacturer0000api.fda.gov
Dentis Co., Ltd.Daegu, South KoreaManufacturer0000api.fda.gov
Dentozone CorporationGuro-gu Seoul, South KoreaManufacturer0000api.fda.gov
DIO CorporationHaeundae-gu Busan, South KoreaManufacturer0000api.fda.gov
Dongguan Yilong Medical Supplies Co.. Ltd.Dongguan Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
E.M.S. Electro Medical Systems S.A.NYON Vaud, SwitzerlandComplaint file establishment, Specification developer0000api.fda.gov
Eldo S.R.LVallesaccarda Campania, ItalyManufacturer0000api.fda.gov
Forefront (xiamen) Medical Devices Co., Ltd.Xiamen Fujian, ChinaContract manufacturer0000api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Fomed Industries IncQian Jiang Hubei, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Garish ApparelsWazirabad Punjab, PakistanManufacturer0000api.fda.gov
GARNET DENTECH CorpDaegu, South KoreaManufacturer0000api.fda.gov
Gate Dental Services LtdGalway Galway(County), IrelandManufacturer0000api.fda.gov
GC Orthodontics America Inc.Alsip, IL, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler0000api.fda.gov
Gestenco International ABGOTEBORG Vastra Gotaland, SwedenManufacturer0000api.fda.gov
Glorious Mercantile Corp. (pvt) Ltd.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Great Lakes Dental Technologies, Ltd.Tonawanda, NY, United StatesManufacturer0000api.fda.gov
Guangdong Xinuo Personal Care Products Co., LtdYunfu City Guangdong, ChinaManufacturer0000api.fda.gov
H & H Co.Hayden, ID, United StatesContract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
Hager & Werken GMBHDUISBURG,DE-NOTA Hamburg, GermanyExporter to the US, Manufacturer0000api.fda.gov
Hangzhou Chohotech Co., LtdHangzhou Zhejiang, ChinaManufacturer0000api.fda.gov
Henan Baistra Medical Devices LimitedZhengzhou Henan, ChinaExporter to the US, Manufacturer0000api.fda.gov
Hexamed Pvt LtdSialkot Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
Hilbro Instruments (pvt) Ltd.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Hilbro International (pvt) LimitedSIALKOT Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
Hospimed MFGSialkot Punjab, PakistanManufacturer0000api.fda.gov
Huanghua DK Dental Co., LtdHuangHua Hebei, ChinaManufacturer0000api.fda.gov
Huanghua Promisee Dental Co., LtdHuanghua Hebei, ChinaManufacturer0000api.fda.gov
Hubei Guarddent Medical Technology Co.,ltdWuhan Hubei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Inion OYTAMPERE Pirkanmaa, FinlandManufacturer, Specification developer0000api.fda.gov
IPB IncOgden, UT, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Ivoclar Vivadent AGSchaan, LiechtensteinSpecification developer0000api.fda.gov
J & J Instruments, LLCNorthbrook, IL, United StatesSpecification developer0000api.fda.gov
J. Morita Usa, Inc.Irvine, CA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Jay-MedSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
JJGC Industria e Comercio de Materiais Dentarios SACuritiba Parana, BrazilManufacturer0000api.fda.gov
Kohler Medizintechnik GmbHSTOCKACH Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Lacigrus InternationalSialkot Punjab, PakistanManufacturer0000api.fda.gov
Leone SPASesto Fiorentino Firenze, ItalyManufacturer0000api.fda.gov
Libral Traders Pvt. Ltd.New Delhi, IndiaManufacturer0000api.fda.gov
Mectalent Ltd.Oulu Kainuu, FinlandContract manufacturer0000api.fda.gov
Medcave Private LimitedSialkot Punjab, PakistanManufacturer0000api.fda.gov
MEDESY srlMANIAGO Pordenone, ItalyManufacturer0000api.fda.gov
NichrominoxSAINT BONNET DE MURE Rhone, FranceManufacturer0000api.fda.gov
Ningbo Aolbea Oral Care Products Co., LtdYuyao City Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
North Eos Industries, Inc.Taichung City, TaiwanManufacturer0000api.fda.gov
Nucare LLCMontclair, CA, United StatesSpecification developer0000api.fda.gov
Nova InstrumentsBerkshire Wokingham, United KingdomContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Orthopli Corp.Philadelphia, PA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Osstem Implant Co., Ltd.Gangseo-gu Seoul, South KoreaSpecification developer0000api.fda.gov
Osstem Implant Co., Ltd.Haeundae-gu Busan, South KoreaManufacturer0000api.fda.gov
Ortho Solutions LCLake Saint Louis, MO, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Philips Oral Healthcare, LLCBothell, WA, United StatesSpecification developer0000api.fda.gov
Phoenix Instruments, Inc.Lisle, IL, United StatesContract manufacturer0000api.fda.gov
Plastics Plus Technology, Inc.Redlands, CA, United StatesContract manufacturer0000api.fda.gov
Practicon, Inc.Greenville, NC, United StatesSpecification developer0000api.fda.gov
Prodont-Holliger S.A.S.OLLIERGUES Puy-de-Dome, FranceManufacturer0000api.fda.gov
Pascal International, Inc.Bellevue, WA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Perfect Group Corp. Ltd.yangzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Quality Aspirators, Inc.Dallas, TX, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Quality Aspirators, Inc.Duncanville, TX, United StatesManufacturer0000api.fda.gov
Quality Concept (pvt) Ltd.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Ready Set ImportBeverly Hills, CA, United StatesSpecification developer0000api.fda.gov
Reliance Orthodontic Products, Inc.Itasca, IL, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
SFS Group Hungary KFT.Janossomorja Gyor-Moson-Sopron, HungaryExporter to the US, Manufacturer0000api.fda.gov
SFS Group Schweiz AG, KUNSTSTOFFWERKAltstaetten Sankt Gallen, SwitzerlandManufacturer0000api.fda.gov
SGS Export Intl.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Shandong Zhushi Pharmaceutical Group Co., LtdHeze Shandong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Shanghai Alwings Medical Instrument Co.,ltd.Shanghai, ChinaManufacturer0000api.fda.gov
Shanghai Kangqiao Dental Instruments FactoryShanghai, ChinaExporter to the US, Manufacturer0000api.fda.gov
Shenzhen Denco Medical Co., Ltd.Shenzhen Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Shenzhen Rogin Medical Co., Ltdshenzhen Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Sinntech Medical (private) LimitedSialkot Punjab, PakistanManufacturer0000api.fda.gov
Smile Line SASt-Imier Bern, SwitzerlandManufacturer0000api.fda.gov
Sobytek Instruments Co.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Solventum Us LLCEagan, MN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Sonendo, Inc.Laguna Hills, CA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Stone Instruments Co.SIALKOT Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
Storz Am Mark GMBHEMMINGEN-LIPTINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Sure Dent CorporationSEONGNAM-SI Gyeonggi, South KoreaManufacturer0000api.fda.gov
Saga Dental Supply ASKongsvinger Hedmark, NorwayContract manufacturer, Manufacturer0000api.fda.gov
Sanbor Medical Xiamen, Inc.Xiamen Fujian, ChinaContract manufacturer0000api.fda.gov
Shenzhen Senlede Technologies Co., LtdShenzhen Guangdong, ChinaContract manufacturer, Exporter to the US0000api.fda.gov
Solventum US LLCIrvine, CA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Suzhou Pac-Dent Technology Co., LtdSUZHOU CITY Jiangsu, ChinaContract manufacturer0000api.fda.gov
Taizhou Rich Medical Products Co., Ltd.TAIZHOU Jiangsu, ChinaManufacturer0000api.fda.gov
Technimen SkillersSIALKOT Punjab, PakistanExporter to the US, Manufacturer0000api.fda.gov
Tontarra Medizintechnik GMBHWURMLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Tor VM Ltd.Moscow Moskva, RussiaManufacturer0000api.fda.gov
TP Orthodontics, Inc.La Porte, IN, United StatesManufacturer0000api.fda.gov
Unip Plastic Industries Sdn BhdCHERAS Selangor, MalaysiaContract manufacturer0000api.fda.gov
Ustomed Instrumente GMBH & Co. KGTuttlingen Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Xiantao S&J Protective Products Co., LtdXiantao Hubei, ChinaManufacturer0000api.fda.gov
Xinhua Surgical Instrument Co. Ltd.ZIBO Shandong, ChinaManufacturer0000api.fda.gov
Zhejiang Jasmine Oralcare Products Co., Ltd.Jiaxing Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Zhejiang Yamei Medical Equipment Technology Co., Ltd.Yang Jiao Lang Zin'an Town Zhejiang, ChinaManufacturer0000api.fda.gov
ZOGEAR Medical Co., Ltd.Yizheng Jiangsu, ChinaManufacturer0000api.fda.gov
Zyris, Inc.Santa Barbara, CA, United StatesManufacturer0000api.fda.gov
iBrite Suzhou Technology Co., LtdSUZHOU CITY Jiangsu, ChinaContract manufacturer0000api.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.