FDA product code NYL: Handpiece, Air-Powered, Root Canal Irrigation
NYL is the FDA product code for handpiece, air-powered, root canal irrigation. It is a Class I device, regulated under 21 CFR 872.4200 and reviewed by the Dental panel. FDA has cleared 5 510(k) submissions under NYL, from 5 different applicants. The average 510(k) review took 153 days (median 112).
Definition
To clean the root canal prior to filling and used for root canal irrigation.
Classification
| Field | Value |
|---|---|
| Device name | Handpiece, Air-Powered, Root Canal Irrigation |
| Device class | Class I |
| Regulation | 21 CFR 872.4200 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for NYL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 181 |
Compare with all 510(k) review times · Search every NYL clearance
Top NYL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Inter-Med, Inc. | 1 | 2021-12-02 |
| Kerr Corporation | 1 | 2016-12-21 |
| Sybron Endo | 1 | 2014-07-02 |
| Redent Nova, Ltd. | 1 | 2010-05-28 |
| Air Techniques, Inc. | 1 | 2006-05-26 |
Most recent NYL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K211721 | Inter-Med, Inc. | PS System | 2021-12-02 | 181 |
| K162436 | Kerr Corporation | EndoVac Pure | 2016-12-21 | 112 |
| K140685 | Sybron Endo | ENDO VAC APICAL NEGATIVE PRESSURE IRIGATION SYSTEM | 2014-07-02 | 106 |
| K100606 | Redent Nova, Ltd. | VATEA ENDONTIC IRRIGATION SYSTEM | 2010-05-28 | 86 |
| K052271 | Air Techniques, Inc. | RINSENDO | 2006-05-26 | 280 |
Recalls for NYL devices
openFDA lists no recalls for product code NYL.
Frequently asked questions
What is FDA product code NYL?
NYL is the FDA product code for handpiece, air-powered, root canal irrigation. It is a Class I device, regulated under 21 CFR 872.4200 and reviewed by the Dental panel.
What device class is NYL?
Class I, regulation 21 CFR 872.4200. Typical premarket route: 510(k).
How long does a 510(k) take for product code NYL?
Across 5 cleared submissions the average was 153 days from receipt to decision (median 112).
Which companies have the most NYL clearances?
Inter-Med, Inc. (1); Kerr Corporation (1); Sybron Endo (1); Redent Nova, Ltd. (1); Air Techniques, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NYL
- Run a recall and safety report across every NYL manufacturer
- Watch product code NYL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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