← Product Code [EHK](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EHK) · K953628

# PROPHY ANGLE (K953628)

_Rolence Enterprise Co. , Ltd. · EHK · Sep 29, 1995 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EHK/K953628

## Device Facts

- **Applicant:** Rolence Enterprise Co. , Ltd.
- **Product Code:** [EHK](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EHK.md)
- **Decision Date:** Sep 29, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.6290
- **Device Class:** Class 1
- **Review Panel:** Dental

## Regulatory Identification

A prophylaxis cup is a device made of rubber intended to be held by a dental handpiece and used to apply polishing agents during prophylaxis (cleaning). The dental handpiece spins the rubber cup holding the polishing agent and the user applies it to the teeth to remove debris.

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EHK/K953628](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EHK/K953628)

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