Dental Hygiene Kit
The Dental Hygiene Kit (product code NXZ) is a Class 1 dental convenience kit established under the May 1997 Convenience Kits Interim Regulatory Guidance, regulated under 21 CFR 872.6855 within the Dental specialty. It is GMP-exempt and under enforcement discretion, meaning it does not require a 510(k) if all criteria in the guidance are met. The device carries no implant or life-sustaining flags.
Research product code NXZ in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- NXZ
- Device Class
- FDA class 1
- Regulation Number
- 872.6855
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 7
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 49 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 49 registration numbers. Click on an entry to view related FDA registrations.