← Product Code [EHK](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EHK) · K780198

# PROPHY CUPS, R&R (K780198)

_Ransom and Randolph · EHK · Feb 16, 1978 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EHK/K780198

## Device Facts

- **Applicant:** Ransom and Randolph
- **Product Code:** [EHK](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EHK.md)
- **Decision Date:** Feb 16, 1978
- **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/K780198](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EHK/K780198)

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