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Data / Medical devices / Gauge, Depth, Instrument, Dental

Gauge, Depth, Instrument, Dental (EIL): 110 FDA-registered makers in 14 countries

110 establishments in 14 countries are registered with the FDA to make Gauge, Depth, Instrument, Dental (product code EIL, 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 8 510(k) clearances under this code, the latest on July 9, 1991, 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.

Get every maker of this deviceMakers in the United StatesWatch this device
Product code
EIL
Device class
1
Regulation
872.4565
Medical specialty
Dental

Makers by country

CountryMakers
United States33
Pakistan25
Germany12
China11
South Korea9
Switzerland5
Brazil3
Italy3
Mexico2
Japan2
India2
Sweden1
Australia1
Israel1

Makers of Gauge, Depth, 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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
A. Schweickhardt GMBH & Co. KGSeitingen-Oberflacht Baden-Wurttemberg, GermanyManufacturer, Repackager or relabeler0000api.fda.gov
A.handte Medizintechnik GMBH & Co. KGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Accompany SurgicalSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Acme EnterprisesSialkot Punjab, PakistanManufacturer0000api.fda.gov
Airway Management Inc.Farmers Branch, TX, United StatesManufacturer0000api.fda.gov
Alta Smiles, LLCFort Washington, PA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Ameda Instruments CompanyKarachi Sindh, PakistanManufacturer0000api.fda.gov
Angelus Industria De Productos OdontologicosLONDRINA Parana, BrazilManufacturer0000api.fda.gov
B. Ali ImpexSIALKOT, Punjab, PakistanManufacturer0000api.fda.gov
Bicon, LLCBoston, MA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Biotem Co., Ltd.Busan, South KoreaManufacturer0000api.fda.gov
Basic Dental Implant Systems, Inc.Rio Rancho, NM, United StatesManufacturer0000api.fda.gov
Calibaja Manufacturing, S.A. De C.V.MEXICALI Baja California, MexicoContract manufacturer0000api.fda.gov
Cangzhou Lankang Medical Instruments Developing Co., Ltd.Cangzhou Hebei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Comfort Surgical InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Confident InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Cislak Manufacturing, Inc.Niles, IL, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Complexus MedicalMishawaka, IN, United StatesContract manufacturer0000api.fda.gov
Daddy D ProSialkot Punjab, PakistanManufacturer0000api.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
Den Tag S.R.L.MANIAGO, PN. Pordenone, ItalyManufacturer0000api.fda.gov
Denta Craft InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Dental StudioAnyang-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Dentalmaster (xiamen) Medical Technology Co., Ltd.Xiamen Fujian, ChinaManufacturer0000api.fda.gov
Dentech Corp.Tokyo, JapanContract manufacturer, Manufacturer0000api.fda.gov
Dentium Co., Ltd.Suwon-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Dentsply Industria E Comercio LtdaPIRASSUNUNGA Sao Paulo, BrazilContract manufacturer0000api.fda.gov
Devemed GMBHNEUHAUSEN OB ECK Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Diadent Group InternationalCHONGJU CITY Chungbuk, South KoreaManufacturer0000api.fda.gov
Directa ABUPPLANDS VAESBY Stockholm, SwedenManufacturer0000api.fda.gov
Dentaurum GmbH & Co. KGISPRINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Eoca MD Pty LimitedDouble Bay New South Wales, AustraliaManufacturer0000api.fda.gov
Essential Dental Systems, Inc.S Hackensack, NJ, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
EverBrands, Inc.Garden Grove, CA, United StatesManufacturer0000api.fda.gov
FKG Dentaire SarlLE CRET-DU-LOCLE Neuchatel, SwitzerlandManufacturer0000api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
GC Orthodontics America Inc.Alsip, IL, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler0000api.fda.gov
Gulmag InternationalSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Gunmed Technik AGWELSCHENROHR Solothurn, SwitzerlandContract manufacturer, Manufacturer0000api.fda.gov
Gesco Healthcare Private LimitedCHENNAI, Tamil Nadu, IndiaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Hdi Inc.Seongnam-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Hebumedical GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Helmut Zepf Medizintechnik GMBHSEITINGEN Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer0000api.fda.gov
HSG-S CorpSavannah, GA, United StatesManufacturer, 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
Intensiv SACollina d'Oro / Montagnola Ticino, SwitzerlandManufacturer0000api.fda.gov
Instrumed International Inc dba Avalign German Specialty InstrumentsSchaumburg, IL, United StatesContract manufacturer, Repackager or relabeler0000api.fda.gov
Integra LifeSciences Production CorporationMansfield, MA, United StatesSpecification developer0000api.fda.gov
J & J Instruments, LLCNorthbrook, IL, United StatesSpecification developer0000api.fda.gov
Jining Orodeka Medical Equipment Co.,ltdJiNing Shandong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Jordco, Inc.Hillsboro, OR, United StatesManufacturer0000api.fda.gov
Julius Wirth LLCEmmingen-Liptingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Keystone Dental Inc.Irvine, CA, United StatesManufacturer0000api.fda.gov
Lacigrus InternationalSialkot Punjab, PakistanManufacturer0000api.fda.gov
Maillefer Instruments Holding SarlBALLAIGUES Vaud, SwitzerlandManufacturer0000api.fda.gov
Medcave Private LimitedSialkot Punjab, PakistanManufacturer0000api.fda.gov
Medimecca Co LtdSeoul, South KoreaManufacturer0000api.fda.gov
Medisporex (pvt) Ltd.SIALKOT Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
Melpex Beauty InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Nextcon InternationalSialkot Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
Nopa Instruments, Medizintechnik GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Oco BiomedicalAlbuquerque, NM, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Ortho Organizers, Inc.Savannah, GA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Orthodontic Manufacturer Sia SRLROCCA D EVANDRO Caserta, ItalyManufacturer0000api.fda.gov
Ossvis Co., Ltd.Anyang-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Osung MND Co., Ltd.Gimpo-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Ot Medical GMBHBremen, GermanyManufacturer0000api.fda.gov
Otto Leibinger GMBHMUEHLHEIM Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Ormco CorporationPomona, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Ormco CorporationBrea, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Pac-Dent Inc.Brea, CA, United StatesSpecification developer0000api.fda.gov
Paltop Advanced Dental Solutions LtdCaesarea Central, IsraelManufacturer0000api.fda.gov
Panorama International.SIALKOT Punjab, PakistanManufacturer0000api.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
Power Dental USA, Inc.McHenry, IL, United StatesManufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
Precision Beauty & Dental Instruments LLCHouston, TX, United StatesSpecification developer0000api.fda.gov
Rhein 83 SRLBOLOGNA Emilia-Romagna, ItalyComplaint file establishment, Manufacturer0000api.fda.gov
Rudolf Storz GMBHEMMINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Sawbros Industries Pvt LtdNOIDA Uttar Pradesh, IndiaManufacturer0000api.fda.gov
Schobell Industrial LtdaRio Claro Sao Paulo, BrazilManufacturer0000api.fda.gov
SDS Swiss Dental SolutionsKreuzlingen Thurgau, SwitzerlandSpecification developer0000api.fda.gov
SDS de Mexico S. de R.L. de C.V.MEXICALI, B.C. C.P. Baja California, MexicoContract manufacturer0000api.fda.gov
Sewon Medix, Inc.Busan, South KoreaManufacturer0000api.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 manufacturer, Manufacturer0000api.fda.gov
Shenzhen Rogin Medical Co., Ltdshenzhen Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Signor Seven InternationalSialkot Punjab, PakistanManufacturer0000api.fda.gov
Storz Am Mark GMBHEMMINGEN-LIPTINGEN Baden-Wurttemberg, GermanyManufacturer, Repackager or relabeler0000api.fda.gov
SurgicraftsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Symmetry Medical Manufacturing IncClaypool, IN, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Symmetry Medical Manufacturing Inc.Warsaw, IN, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Shanghai Jolly Industrial Co., Ltd.Shanghai, ChinaContract manufacturer, Exporter to the US0000api.fda.gov
Solventum Orthodontics CorporationMonrovia, CA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Taurus Engineering And Manufacturing, Inc.Saint Paul, MN, United StatesContract manufacturer0000api.fda.gov
Technimen SkillersSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Towne Brothers (pvt.), Ltd.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Tulsa Dental Products LLCJohnson City, TN, United StatesManufacturer0000api.fda.gov
Ultra Surgical (pvt.) LtdSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
US Endodontics, LLCJohnson City, TN, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Win Wings Corp.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Y. Z. CorporationSIALKOT Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
Ydm CorporationHIGASHIMATSUYAMA-SHI Saitama, JapanManufacturer0000api.fda.gov
Zain's Medical ImageSIALKOT Punjab, PakistanManufacturer0000api.fda.gov

Updated July 9, 1991. 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.