Dental Implant Surgical Tray
The Dental Implant Surgical Tray is a convenience kit that packages the instruments and components required to perform dental implant placement surgery. Despite its name referencing implants, the kit itself is not flagged as an implant device and is classified as FDA Class 1 under regulation 21 CFR 872.3980 within the Dental medical specialty, subject only to general controls. Per 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 criteria are met. The product code is OFY.
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Basic Information
- Product Code
- OFY
- Device Class
- FDA class 1
- Regulation Number
- 872.3980
- 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 23 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 23 registration numbers. Click on an entry to view related FDA registrations.