FDA product code NYF: Gingival Retraction Kit
NYF is the FDA product code for gingival retraction kit. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel. Devices under NYF 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 https://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 | Gingival Retraction Kit |
| Device class | Class I |
| Regulation | 21 CFR 872.4565 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Recalls for NYF devices
openFDA lists no recalls for product code NYF.
Frequently asked questions
What is FDA product code NYF?
NYF is the FDA product code for gingival retraction kit. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel.
What device class is NYF?
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 NYF
- Run a recall and safety report across every NYF manufacturer
- Watch product code NYF 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.