FDA product code NYG: Lapping Tool Kit
NYG is the FDA product code for lapping tool kit. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel. Devices under NYG reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
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 | Lapping Tool Kit |
| Device class | Class I |
| Regulation | 21 CFR 872.4565 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Recalls for NYG devices
openFDA lists no recalls for product code NYG.
Frequently asked questions
What is FDA product code NYG?
NYG is the FDA product code for lapping tool kit. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel.
What device class is NYG?
Class I, regulation 21 CFR 872.4565. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code NYG
- Run a recall and safety report across every NYG manufacturer
- Watch product code NYG 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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