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Data / Medical devices / Knife, Margin Finishing, Operative

Knife, Margin Finishing, Operative (EJZ): 30 FDA-registered makers in 7 countries

30 establishments in 7 countries are registered with the FDA to make Knife, Margin Finishing, Operative (product code EJZ, 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 2 510(k) clearances under this code, the latest on October 9, 1987, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
EJZ
Device class
1
Regulation
872.4565
Medical specialty
Dental

Makers by country

CountryMakers
Pakistan12
United States8
Germany5
South Korea2
Italy1
India1
Brazil1

Makers of Knife, Margin Finishing, Operative

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, PakistanManufacturer0000api.fda.gov
Aesculap AGTUTTLINGEN, DONAU Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Aceonedent Korea lnd. Co.BUCHUN-SI Gyeonggi, South KoreaManufacturer0000api.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
Den Tag S.R.L.MANIAGO, PN. Pordenone, ItalyManufacturer0000api.fda.gov
Denta Craft InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Dimeda Instrumente GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Gesco Healthcare Private LimitedCHENNAI, Tamil Nadu, IndiaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Harf IndustriesSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Helmut Zepf Medizintechnik GMBHSEITINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Hilbro Instruments (pvt) Ltd.SIALKOT Punjab, PakistanManufacturer0000api.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
Integra LifeSciences Production CorporationMansfield, MA, United StatesManufacturer0000api.fda.gov
J & J Instruments, LLCNorthbrook, IL, United StatesSpecification developer0000api.fda.gov
Kohler Medizintechnik GmbHSTOCKACH Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Med2b Ltd.Kitzingen Bavaria, GermanyManufacturer0000api.fda.gov
Medcave Private LimitedSialkot Punjab, PakistanManufacturer0000api.fda.gov
Osung MND Co., Ltd.Gimpo-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Panorama International.SIALKOT 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
Schobell Industrial LtdaRio Claro Sao Paulo, BrazilManufacturer0000api.fda.gov
Sinntech Medical (private) LimitedSialkot Punjab, PakistanManufacturer0000api.fda.gov
Towne Brothers (pvt.), Ltd.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Ultra Surgical (pvt.) LtdSIALKOT Punjab, PakistanManufacturer0000api.fda.gov

Updated October 9, 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.