← Product Code [EIE](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EIE) · K921771

# MINIDAM II (K921771)

_Delsan Dental Systems · EIE · Sep 17, 1992 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EIE/K921771

## Device Facts

- **Applicant:** Delsan Dental Systems
- **Product Code:** [EIE](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EIE.md)
- **Decision Date:** Sep 17, 1992
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.6300
- **Device Class:** Class 1
- **Review Panel:** Dental

## Regulatory Identification

A rubber dam and accessories is a device composed of a thin sheet of latex with a hole in the center intended to isolate a tooth from fluids in the mouth during dental procedures, such as filling a cavity preparation. The device is stretched around a tooth by inserting a tooth through a hole in the center. The device includes the rubber dam, rubber dam clamp, rubber dam frame, and forceps for a rubber dam clamp. This classification does not include devices intended for use in preventing transmission of sexually transmitted diseases through oral sex; those devices are classified as condoms in § 884.5300 of this chapter.

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EIE/K921771](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EIE/K921771)

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