Restorative Instrument And Component Tray
The Restorative Instrument and Component Tray is a convenience kit that combines dental restorative instruments and components used in procedures such as tooth-colored or amalgam restorations. It is FDA Class 2 under regulation 21 CFR 872.3690, falling within the Dental medical specialty; under the FDA's May 1997 Convenience Kits Interim Regulatory Guidance it is under enforcement discretion and does not require a 510(k) submission if all guidance criteria are satisfied. The product code is OFW. It is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- OFW
- Device Class
- FDA class 2
- Regulation Number
- 872.3690
- 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 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.