NYE — Fixture Mount Kit Class I
FDA product code NYE covers "Fixture Mount Kit", a Class I medical device regulated under 21 CFR 872.3980. Submissions are reviewed by the Dental panel.
Classification Details
- Product Code
- NYE
- Device Class
- Class I
- Regulation Number
- 872.3980
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Definition
Fixture dental mount kit may contain hand instruments, drill bits, and screw drivers. 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.