FDA product code NYE: Fixture Mount Kit
NYE is the FDA product code for fixture mount kit. It is a Class I device, regulated under 21 CFR 872.3980 and reviewed by the Dental panel. Devices under NYE reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
Fixture dental mount kit may contain hand instruments, drill bits, and screw drivers. 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 | Fixture Mount Kit |
| Device class | Class I |
| Regulation | 21 CFR 872.3980 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Recalls for NYE devices
openFDA lists no recalls for product code NYE.
Frequently asked questions
What is FDA product code NYE?
NYE is the FDA product code for fixture mount kit. It is a Class I device, regulated under 21 CFR 872.3980 and reviewed by the Dental panel.
What device class is NYE?
Class I, regulation 21 CFR 872.3980. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code NYE
- Run a recall and safety report across every NYE manufacturer
- Watch product code NYE 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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