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Data / Medical devices / Pin, Retentive And Splinting, And Accessory Instruments

Pin, Retentive And Splinting, And Accessory Instruments (EBL): 36 FDA-registered makers in 15 countries

36 establishments in 15 countries are registered with the FDA to make Pin, Retentive And Splinting, And Accessory Instruments (product code EBL, Class 1, 21 CFR 872.3740). 0 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 11 510(k) clearances under this code, the latest on November 9, 2000, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.

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Product code
EBL
Device class
1
Regulation
872.3740
Medical specialty
Dental

Makers by country

CountryMakers
United States9
Germany7
China4
Pakistan2
South Korea2
India2
Switzerland2
Israel1
Brazil1
Sweden1
Liechtenstein1
Australia1
United Kingdom1
Turkey1
Italy1

Makers of Pin, Retentive And Splinting, And Accessory Instruments

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
Abracadabra Implants Ltd.Or Yehuda Central, IsraelRepackager or relabeler, Specification developer0000api.fda.gov
Accumedix, Inc.Libertyville, IL, United StatesContract manufacturer0000api.fda.gov
Angelus Industria De Productos OdontologicosLONDRINA Parana, BrazilManufacturer0000api.fda.gov
B. Ali ImpexSIALKOT, Punjab, PakistanManufacturer0000api.fda.gov
Biotem Co., Ltd.Busan, South KoreaManufacturer0000api.fda.gov
Blue Sky Bio, LLCLibertyville, IL, United StatesSpecification developer0000api.fda.gov
Brasseler U.S.A. Dental, LLCSavannah, GA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Bredent GMBH & Co.kgSENDEN Bavaria, GermanyManufacturer0000api.fda.gov
Cangzhou Lankang Medical Instruments Developing Co., Ltd.Cangzhou Hebei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Changsha Nice Medical Instrument Limited CompanyChangsha Hunan, ChinaManufacturer0000api.fda.gov
CM Instrumente GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Coltene/Whaledent Inc.Cuyahoga Falls, OH, United StatesManufacturer0010api.fda.gov
Cynosure, LLCWestford, MA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Dentatus ABSPANGA Stockholm, SwedenManufacturer0000api.fda.gov
Dentistry ElevatedWellsville, UT, United StatesManufacturer0000api.fda.gov
Dufner Instrumente GMBHTUTTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Dentaurum GmbH & Co. KGISPRINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Edenta EtablissementSCHAANWALD Mauren, LiechtensteinManufacturer0000api.fda.gov
Erskine DentalMACKSVILLE New South Wales, AustraliaExporter to the US, Specification developer0000api.fda.gov
FAIRFAX MEDICAL PRODUCTS LtdLondon London, City of, United KingdomManufacturer0000api.fda.gov
Greens Surgicals Private LimitedVadodara Gujarat, IndiaManufacturer0000api.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
Hager Worldwide, Inc.Hickory, NC, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Harald Nordin S.A.Montreux Vaud, SwitzerlandManufacturer0000api.fda.gov
Hospimed MFGSialkot Punjab, PakistanManufacturer0000api.fda.gov
Imicryl Dis Malzemeleri Sanayi Ve Ticaret A.S.Konya, TurkeyManufacturer0000api.fda.gov
Lenjoy Medical Engineering, Inc.Gardena, CA, United StatesManufacturer0000api.fda.gov
La Maison Dentaire / Medirel SAAgno Ticino, SwitzerlandManufacturer0000api.fda.gov
Mahe Medical UsaLaramie, WY, United StatesComplaint file establishment, Specification developer0000api.fda.gov
MC Bio S.R.L.Lomazzo Como, ItalyManufacturer0000api.fda.gov
Medcare Solutions GMBHEmmingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Osung MND Co., Ltd.Gimpo-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Rudolf Storz GMBHEMMINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.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

Updated November 9, 2000. 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.