OFX — General Purpose Dental Tray Class I
FDA product code OFX covers "General Purpose Dental Tray", a Class I medical device regulated under 21 CFR 872.6640. Submissions are reviewed by the Dental panel.
Classification Details
- Product Code
- OFX
- Device Class
- Class I
- Regulation Number
- 872.6640
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
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.