General Purpose Dental Tray
The General Purpose Dental Tray is a convenience kit containing dental supplies for general-purpose use in clinical dental settings. Classified as FDA Class 1 under regulation 21 CFR 872.6640 within the Dental medical specialty, it is the lowest risk class subject only to general controls; this kit additionally falls under enforcement discretion per the FDA's May 1997 Convenience Kits Interim Regulatory Guidance and does not require a 510(k) submission when all criteria are met. The product code is OFX. It is not designated as an implant or life-sustaining device.
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Basic Information
- Product Code
- OFX
- Device Class
- FDA class 1
- Regulation Number
- 872.6640
- 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 43 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 43 registration numbers. Click on an entry to view related FDA registrations.