← Product Code [EEF](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EEF) · K780744

# BRINKER TISSUE RETRACTORS (K780744)

_Hygienic Dental Mfg., Co., The · EEF · May 12, 1978 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EEF/K780744

## Device Facts

- **Applicant:** Hygienic Dental Mfg., Co., The
- **Product Code:** [EEF](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EEF.md)
- **Decision Date:** May 12, 1978
- **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.

---

**Source:** [https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EEF/K780744](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EEF/K780744)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com