Data / Medical devices / Handpiece, Air-Powered, Root Canal Irrigation
Handpiece, Air-Powered, Root Canal Irrigation (NYL): 4 FDA-registered makers in 2 countries
4 establishments in 2 countries are registered with the FDA to make Handpiece, Air-Powered, Root Canal Irrigation (product code NYL, Class 1, 21 CFR 872.4200). 3 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 December 2, 2021, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- NYL
- Device class
- 1
- Regulation
- 872.4200
- Medical specialty
- Dental
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| Malaysia | 1 |
Makers of Handpiece, Air-Powered, Root Canal Irrigation
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 |
|---|---|---|---|---|---|---|---|---|
| Inter-Med, Inc. | Racine, WI, United States | Complaint file establishment, Manufacturer | 1 | December 2, 2021 | 0 | 0 | 0 | api.fda.gov |
| Kerr Corporation | Orange, CA, United States | Complaint file establishment, Specification developer | 1 | July 2, 2014 | 0 | 0 | 0 | api.fda.gov |
| Kerr Corporation | Pomona, CA, United States | Specification developer | 1 | July 2, 2014 | 0 | 0 | 0 | api.fda.gov |
| Unip Plastic Industries Sdn Bhd | CHERAS Selangor, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated December 2, 2021. 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.