Surgical devices · 21 CFR 872 Subpart E
Root Canal Irrigation Air-Powered Handpiece
To clean the root canal prior to filling and used for root canal irrigation.
- Companies listing it
- 43 makers
- Brands and models
- 3
- 510(k) clearances
- 62 in five years
- FDA name
- Handpiece, Air-Powered, Root Canal Irrigation
510(k) clearances per year, 1976–2026
Companies that list NYL
4 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Sybron Dental Specialties | United States | Maker | EndoVac Apical Negative Pressure Irrigation System | 203 | 2026 |
| Inter-Med, Inc. | United States | Maker | Pulpsucker (PS) System | 7 | 2026 |
| Unip Berhad | Malaysia | Maker | ENDOVAC HANDPIECE, AIR-POWERED, ROOT CANAL IRRIGATION SYRINGE | — | — |
| Sanicure BV | Netherlands | Foreign exporter | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 29 Oct 2026 | K260356 | EndoColibri | Koehrer Medical Engineering GmbH |
| 2 Dec 2021 | K211721 | PS System | Inter-Med, Inc. |
| 21 Dec 2016 | K162436 | EndoVac Pure | Sybron Dental Specialties |
| 2 Jul 2014 | K140685 | ENDO VAC APICAL NEGATIVE PRESSURE IRIGATION SYSTEM | Sybron Endo |
| 28 May 2010 | K100606 | VATEA ENDONTIC IRRIGATION SYSTEM | Redent Nova, Ltd. |
| 26 May 2006 | K052271 | RINSENDO | Duerr Dental SE |
Official records: FDA product classification for NYL · 21 CFR 872.4200.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026