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
| Country | Makers |
|---|---|
| Pakistan | 12 |
| United States | 8 |
| Germany | 5 |
| South Korea | 2 |
| Italy | 1 |
| India | 1 |
| Brazil | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Accompany Surgical | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aesculap AG | TUTTLINGEN, DONAU Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aceonedent Korea lnd. Co. | BUCHUN-SI Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Comfort Surgical Instruments | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Confident Instruments | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cislak Manufacturing, Inc. | Niles, IL, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Den Tag S.R.L. | MANIAGO, PN. Pordenone, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Denta Craft Instruments | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dimeda Instrumente GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Falcon Surgical Co. (Pvt.) Ltd. | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gesco Healthcare Private Limited | CHENNAI, Tamil Nadu, India | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Harf Industries | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Helmut Zepf Medizintechnik GMBH | SEITINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hilbro Instruments (pvt) Ltd. | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hu-Friedy MFG Co., LLC | Des Plaines, IL, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hu-Friedy MFG. Co. LLC | Northbrook, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Integra LifeSciences Production Corporation | Mansfield, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| J & J Instruments, LLC | Northbrook, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kohler Medizintechnik GmbH | STOCKACH Baden-Wurttemberg, Germany | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Med2b Ltd. | Kitzingen Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medcave Private Limited | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Osung MND Co., Ltd. | Gimpo-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Panorama International. | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Premier Dental Products Co. | Plymouth Meeting, PA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Premier Medical | Philadelphia, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Power Dental USA, Inc. | McHenry, IL, United States | Manufacturer, Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Schobell Industrial Ltda | Rio Claro Sao Paulo, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sinntech Medical (private) Limited | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Towne Brothers (pvt.), Ltd. | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ultra Surgical (pvt.) Ltd | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.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.