FDA product code NYC: Dental Prophylaxis Kit
NYC is the FDA product code for dental prophylaxis kit. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel. Devices under NYC 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 http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf.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 | Dental Prophylaxis Kit |
| Device class | Class I |
| Regulation | 21 CFR 872.4565 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Recalls for NYC devices
openFDA lists no recalls for product code NYC.
Frequently asked questions
What is FDA product code NYC?
NYC is the FDA product code for dental prophylaxis kit. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel.
What device class is NYC?
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 NYC
- Run a recall and safety report across every NYC manufacturer
- Watch product code NYC 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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