FDA product code NYD: Endodontic Kit
NYD is the FDA product code for endodontic kit. It is a Class II device, regulated under 21 CFR 872.3820 and reviewed by the Dental panel. Devices under NYD reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for NYD devices, 1 initiated in the last five years.
Definition
This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Classification
| Field | Value |
|---|---|
| Device name | Endodontic Kit |
| Device class | Class II |
| Regulation | 21 CFR 872.3820 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Recalls for NYD devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-11-02.
| Year | Recalls |
|---|---|
| 2022 | 1 |
Frequently asked questions
What is FDA product code NYD?
NYD is the FDA product code for endodontic kit. It is a Class II device, regulated under 21 CFR 872.3820 and reviewed by the Dental panel.
What device class is NYD?
Class II, regulation 21 CFR 872.3820. Typical premarket route: 510(k) exempt.
Have NYD devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2022-11-02.
Next steps
- Run an FDA pathway report with predicate devices for product code NYD
- Run a recall and safety report across every NYD manufacturer
- Watch product code NYD 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.
All Dental product codes · FDA product code lookup · 510(k) database search · 510(k) review times