# Lapping Tool Kit
> **Product code: NYG** · Class I — Low Risk (general controls) · Dental · 21 CFR 872.4565
## Classification
- **FDA Product Code:** NYG
- **Device class:** Class I — Low Risk (general controls)
- **Regulation:** 21 CFR 872.4565
- **Review panel:** DE
- **Medical specialty:** Dental
- **Submission type:** 7
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 10
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=NYG)
---
*AI Analytics · CC0 1.0*