← Product Code [EGS](/submissions/DE/subpart-e%E2%80%94surgical-devices/EGS) · K945834

# PROPHY PRO. (K945834)

_Hyman, Phelps & McNamara, P.C. · EGS · Feb 13, 1995 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EGS/K945834

## Device Facts

- **Applicant:** Hyman, Phelps & McNamara, P.C.
- **Product Code:** [EGS](/submissions/DE/subpart-e%E2%80%94surgical-devices/EGS.md)
- **Decision Date:** Feb 13, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.4200
- **Device Class:** Class 1
- **Review Panel:** Dental

## Regulatory Identification

A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EGS/K945834](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EGS/K945834)

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