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Data / Medical devices / Instrument, Filling, Plastic, Dental

Instrument, Filling, Plastic, Dental (EIY): 141 FDA-registered makers in 18 countries

141 establishments in 18 countries are registered with the FDA to make Instrument, Filling, Plastic, Dental (product code EIY, 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 5 510(k) clearances under this code, the latest on May 27, 1987, 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
EIY
Device class
1
Regulation
872.4565
Medical specialty
Dental

Makers by country

CountryMakers
Pakistan57
United States24
China21
Germany18
South Korea5
Switzerland3
Italy2
Malaysia1
Serbia1
Denmark1
India1
Japan1
Canada1
France1
United Kingdom1
Taiwan1
Brazil1
Poland1

Makers of Instrument, Filling, Plastic, 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
A. Schweickhardt GMBH & Co. KGSeitingen-Oberflacht Baden-Wurttemberg, GermanyManufacturer, Repackager or relabeler0000api.fda.gov
Accompany SurgicalSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Acme EnterprisesSialkot Punjab, PakistanManufacturer0000api.fda.gov
Aesculap AGTUTTLINGEN, DONAU Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
ALVI ExpoSialkot Punjab, PakistanManufacturer0000api.fda.gov
American Eagle InstrumentsMissoula, MT, United StatesManufacturer0000api.fda.gov
Anqing Clean Dental Instrument Technology Co.,ltdAnqing City Anhui, ChinaExporter to the US, Manufacturer0000api.fda.gov
Armatech InternationalSialkot Punjab, PakistanManufacturer0000api.fda.gov
B. Ali ImpexSIALKOT, Punjab, PakistanManufacturer0000api.fda.gov
B. Braun Medical Industries Sdn. Bhd.PENANG Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Baeramed Instrumente GMBHSCHWENNINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
BAK KOHLER Medical KGNEUHAUSEN OB ECK-Schwandorf Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Brasseler U.S.A. Dental, LLCSavannah, GA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
BioMTADaejeon, South KoreaManufacturer0000api.fda.gov
Bioclear Matrix Systems, LLCTacoma, WA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Central Surgical Co. Pvt. Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Centrix, Inc.Shelton, CT, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Changzhou Bomedent Medical Technology Co., LtdChangzhou Jiangsu, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Chengdu Sani Medical Equipment Co.,ltd.Chengdu Sichuan, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Choose Surgical InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Comfort Surgical InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Concise EnterprisesSialkot Punjab, PakistanManufacturer0000api.fda.gov
Confident InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Creanova DooBelgrade Vojvodina, SerbiaContract manufacturer0000api.fda.gov
Cislak Manufacturing, Inc.Niles, IL, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Daddy D ProSialkot Punjab, PakistanManufacturer0000api.fda.gov
Darleys Surgical Co.Sialkot, Punjab, PakistanManufacturer0000api.fda.gov
Den Tag S.R.L.MANIAGO, PN. Pordenone, ItalyManufacturer0000api.fda.gov
Denbur, Inc.Westmont, IL, United StatesManufacturer0000api.fda.gov
Densol International (private) LimitedSialkot Punjab, PakistanManufacturer0000api.fda.gov
Denta Craft InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Devemed GMBHNEUHAUSEN OB ECK Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Dimeda Instrumente GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Dentsply Sirona Orthodontics Inc.Sarasota, FL, United StatesManufacturer0000api.fda.gov
Elite Dental LabHuizhou City Guangdong, ChinaManufacturer0000api.fda.gov
Emerald InstrumentsSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Endo Tech InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Ergodenta ApsTaastrup Hovedstaden, DenmarkContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Essential Dental Systems, Inc.S Hackensack, NJ, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
FKG Dentaire SarlLE CRET-DU-LOCLE Neuchatel, SwitzerlandManufacturer0000api.fda.gov
Foshan Coxo Medical Instrument Co., Ltd.Foshan Guangdong, ChinaManufacturer0000api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Garish ApparelsWazirabad Punjab, PakistanManufacturer0000api.fda.gov
Garrison Dental SolutionsSpring Lake, MI, United StatesComplaint file establishment, Contract manufacturer, Specification developer0000api.fda.gov
Gebr. Brasseler GMBH & Co. KGLEMGO North Rhine-Westphalia, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Goldman Products, Inc.Wauconda, IL, United StatesContract manufacturer, Manufacturer, Remanufacturer0000api.fda.gov
Gesco Healthcare Private LimitedCHENNAI, Tamil Nadu, IndiaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Hager & Werken GMBHDUISBURG,DE-NOTA Hamburg, GermanyManufacturer0000api.fda.gov
Hazel EnterprisesSialkot Punjab, PakistanManufacturer0000api.fda.gov
Hefei Mlush Sanitary Products Co.,ltdHefei Anhui, ChinaManufacturer0000api.fda.gov
Helmut Zepf Medizintechnik GMBHSEITINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Henan Baistra Medical Devices LimitedZhengzhou Henan, ChinaExporter to the US, Manufacturer0000api.fda.gov
HERMANN MUELLER Medizintechnik GmbHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer, 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
Hive International Pvt Ltd.Sialkot Punjab, PakistanManufacturer, Repackager or relabeler0000api.fda.gov
Hu-Friedy MFG Co., LLCDes Plaines, IL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Hu-Friedy MFG. Co. LLCNorthbrook, IL, United StatesManufacturer0000api.fda.gov
Huanghua DK Dental Co., LtdHuangHua Hebei, ChinaManufacturer0000api.fda.gov
Huanghua Promisee Dental Co., LtdHuanghua Hebei, ChinaManufacturer0000api.fda.gov
Hefei Xingcheng Sanitary Products CO.,LTDHefei Anhui, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Infirmary Medical SuppliesSialkot Punjab, PakistanManufacturer0000api.fda.gov
J & J Instruments, LLCNorthbrook, IL, United StatesSpecification developer0000api.fda.gov
Karl Hammacher GMBHSOLINGEN North Rhine-Westphalia, GermanyManufacturer0000api.fda.gov
Kerr CorporationOrange, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Kohler Medizintechnik GmbHSTOCKACH Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Lacigrus InternationalSialkot Punjab, PakistanManufacturer0000api.fda.gov
Larident S.R.L.TRIBOGNA Genova, ItalyManufacturer0000api.fda.gov
Lohar Medical CompanySialkot Punjab, PakistanManufacturer0000api.fda.gov
Madina Surgical WorksSialkot Punjab, PakistanManufacturer0000api.fda.gov
Maillefer Instruments Holding SarlBALLAIGUES Vaud, SwitzerlandManufacturer0000api.fda.gov
Maryam TradingSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
MctbioYongin-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Medicon, E.G.TUTTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Medisporex (pvt) Ltd.SIALKOT Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
Meed Skills SurgicalSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Melpex Beauty InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Metro MedicalSialkot Punjab, PakistanManufacturer, Repackager or relabeler0000api.fda.gov
Mount Blonck TradingSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
MegaGen Implant Co., Ltd. (Research Laboratories)Daegu, South KoreaSpecification developer0000api.fda.gov
Megagen Implant Co., Ltd.Daegu, South KoreaManufacturer0000api.fda.gov
Mts Brothers Surgical InstrumentsPunjab, PakistanManufacturer0000api.fda.gov
Nadir & Co.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Neo Dental Chemical Products Co., Ltd.Nagano, JapanManufacturer0000api.fda.gov
Nextcon InternationalSialkot Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
Nopa Instruments, Medizintechnik GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Nordent MFG., Inc.Elk Grove Village, IL, United StatesContract manufacturer, Manufacturer0000api.fda.gov
NR Surgical CompanySialkot Punjab, PakistanManufacturer0000api.fda.gov
Odne AGDubendorf Zurich, SwitzerlandComplaint file establishment, Specification developer0000api.fda.gov
Onvet Medical Canada IncTORONTO Ontario, CanadaManufacturer0000api.fda.gov
Osung MND Co., Ltd.Gimpo-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Panorama International.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
PDT, Inc.Msla, MT, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Phoenix Instruments, Inc.Lisle, IL, United StatesContract manufacturer0000api.fda.gov
Pomee CorporationSialkot Punjab, PakistanManufacturer0000api.fda.gov
Premier Dental Products Co.Plymouth Meeting, PA, United StatesSpecification developer0000api.fda.gov
Premier MedicalPhiladelphia, PA, United StatesContract manufacturer0000api.fda.gov
Prodont-Holliger S.A.S.OLLIERGUES Puy-de-Dome, FranceManufacturer0000api.fda.gov
Power Dental USA, Inc.McHenry, IL, United StatesManufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
Qsa Surgical (pvt) Ltd.SIALKOT Punjab, PakistanContract manufacturer0000api.fda.gov
Ready Set ImportBeverly Hills, CA, United StatesSpecification developer0000api.fda.gov
Robinson Healthcare LimitedWorksop Nottinghamshire, United KingdomManufacturer0000api.fda.gov
Sabokay IndustriesSialkot Punjab, PakistanManufacturer0000api.fda.gov
Shandong Hengfeng Kerui Medical Equipment Co., LtdQingdao City Shandong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Shanghai Dochem Industries Co., Ltd.Shanghai, ChinaManufacturer0000api.fda.gov
Shanghai Lions Industrial Co.,ltd.Shanghai, ChinaContract manufacturer, Exporter to the US0000api.fda.gov
Shanghai Medical Instruments (group) Ltd. Corp.Shanghai, ChinaManufacturer0000api.fda.gov
Shenzhen Denco Medical Co., Ltd.Shenzhen Guangdong, ChinaContract sterilizer, Manufacturer0000api.fda.gov
Shenzhen Moye Technology Co LtdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Rogin Medical Co., Ltdshenzhen Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Silver Plus Corp.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Sinntech Medical (private) LimitedSialkot Punjab, PakistanManufacturer0000api.fda.gov
Solatch SonsSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Song Young Intl. Co.Taipei, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Spartech Instruments & Co.Sialkot, Punjab, PakistanManufacturer0000api.fda.gov
Storz Am Mark GMBHEMMINGEN-LIPTINGEN Baden-Wurttemberg, GermanyManufacturer, Repackager or relabeler0000api.fda.gov
Surgicon Pvt LtdSialkot Punjab, PakistanManufacturer0000api.fda.gov
SurgicraftsSialkot Punjab, PakistanManufacturer0000api.fda.gov
SurgikareSIALKOT Punjab, PakistanExporter to the US, Manufacturer0000api.fda.gov
SurgiscapeSialkot Punjab, PakistanManufacturer0000api.fda.gov
Swengg CoSialkot Punjab, PakistanManufacturer0000api.fda.gov
Septodont, IncLancaster, PA, United StatesManufacturer0000api.fda.gov
Shanghai Jolly Industrial Co., Ltd.Shanghai, ChinaContract manufacturer, Exporter to the US0000api.fda.gov
Sterngold Dental LLCAttleboro, MA, United StatesManufacturer0000api.fda.gov
T.A. Walthem & CompanySialkot Punjab, PakistanManufacturer0000api.fda.gov
TDV Dental LtdaPOMERODE Santa Catarina, BrazilContract manufacturer, Manufacturer0000api.fda.gov
Technimen SkillersSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
TF New Material Sci And Tec Co.,ltdHuainan Anhui, ChinaManufacturer0000api.fda.gov
Teufel & Gerlach GmbHTuttlingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Ultra Surgical (pvt.) LtdSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Ustomed Instrumente GMBH & Co. KGTuttlingen Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Ultradent Products Inc.South Jordan, UT, United StatesManufacturer0000api.fda.gov
Verdent Ltd.LODZ Lodzkie, PolandManufacturer0000api.fda.gov
Washington Surgical InternationalSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Win Wings Corp.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Y. Z. CorporationSIALKOT Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
Zain's Medical ImageSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Zepf Medical Instruments GMBHSEITINGEN-OBERFLACHT Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Zhejiang Lidesen Medical Instrument Co., LtdHangzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
ZOGEAR Medical Co., Ltd.Yizheng Jiangsu, ChinaManufacturer0000api.fda.gov

Updated May 27, 1987. 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.