FDA product code NXZ: Dental Hygiene Kit
NXZ is the FDA product code for dental hygiene kit. It is a Class I device, regulated under 21 CFR 872.6855 and reviewed by the Dental panel. Devices under NXZ 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 | Dental Hygiene Kit |
| Device class | Class I |
| Regulation | 21 CFR 872.6855 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for NXZ devices
openFDA lists no recalls for product code NXZ.
Frequently asked questions
What is FDA product code NXZ?
NXZ is the FDA product code for dental hygiene kit. It is a Class I device, regulated under 21 CFR 872.6855 and reviewed by the Dental panel.
What device class is NXZ?
Class I, regulation 21 CFR 872.6855. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code NXZ
- Run a recall and safety report across every NXZ manufacturer
- Watch product code NXZ 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.