NYL
5 FDA 510(k) clearances · Product code
112 daysmedian time to decision
280 days90th percentile
5clearances measured
FDA profile
- Official device name
- Handpiece, Air-Powered, Root Canal Irrigation
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.4200
- Medical specialty
- Dental
- Flags
- Third-party review eligible
- FDA definition
- To clean the root canal prior to filling and used for root canal irrigation.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| PS System (K211721) | Inter-Med, Inc. | 2021-12-02 |
| EndoVac Pure (K162436) | Kerr Corporation | 2016-12-21 |
| ENDO VAC APICAL NEGATIVE PRESSURE IRIGATION SYSTEM (K140685) | Sybron Endo | 2014-07-02 |
| VATEA ENDONTIC IRRIGATION SYSTEM (K100606) | Redent Nova, Ltd. | 2010-05-28 |
| RINSENDO (K052271) | Air Techniques, Inc. | 2006-05-26 |
Track NYL automatically
Every clearance here is in the API, with alerts when new ones post.