# Fixture Mount Kit
> **Product code: NYE** · Class I — Low Risk (general controls) · Dental · 21 CFR 872.3980
## Classification
- **FDA Product Code:** NYE
- **Device class:** Class I — Low Risk (general controls)
- **Regulation:** 21 CFR 872.3980
- **Review panel:** DE
- **Medical specialty:** Dental
- **Submission type:** 7
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 16
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=NYE)
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