# Handpiece, Direct Drive, Ac-Powered
> **Product code: EKX** · Class I — Low Risk (general controls) · Dental · 21 CFR 872.4200
## Classification
- **FDA Product Code:** EKX
- **Device class:** Class I — Low Risk (general controls)
- **Regulation:** 21 CFR 872.4200
- **Review panel:** DE
- **Medical specialty:** Dental
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** Y
## Market data
- **Cleared 510(k) submissions:** 89
- **Registered establishments:** 87
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=EKX)
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