NYLClass I
Handpiece, Air-Powered, Root Canal Irrigation
21 CFR 872.4200 / Dental
NYL is the FDA product code for Handpiece, Air-Powered, Root Canal Irrigation, a class I device type, regulated under 21 CFR 872.4200. FDA's definition for this code reads: "To clean the root canal prior to filling and used for root canal irrigation". As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- NYL
- Device name
- Handpiece, Air-Powered, Root Canal Irrigation
- FDA definition
- To clean the root canal prior to filling and used for root canal irrigation.
- Regulation
- 21 CFR 872.4200
- Device class
- Class I
- Review panel
- Dental
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 5
- Ingested recalls
- 0
Clearances, product code NYL
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2006 | 1 |
| 2010 | 1 |
| 2014 | 1 |
| 2016 | 1 |
| 2021 | 1 |
Applicants with the most clearances
Product code NYL| Applicant | Clearances |
|---|---|
| Air Techniques, Inc. | 1 |
| Inter-Med, Inc. | 1 |
| Sybron Dental Specialties, Inc. | 1 |
| Redent Nova, Ltd. | 1 |
| Sybron Endo | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.