Fixture Mount Kit
The Fixture Mount Kit (product code NYE) is a Class 1 dental convenience kit that may contain hand instruments, drill bits, and screwdrivers used in dental implant fixture mounting procedures, regulated under 21 CFR 872.3980 within the Dental specialty. As a convenience kit under the May 1997 Convenience Kits Interim Regulatory Guidance, it is under enforcement discretion and does not require a 510(k) if all guidance criteria are met. The device carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- NYE
- Device Class
- FDA class 1
- Regulation Number
- 872.3980
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 7
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 16 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 16 registration numbers. Click on an entry to view related FDA registrations.