← Product Code [DYH](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DYH) · K792003

# 1 STEP (K792003)

_Betta Dental, Inc. · DYH · Nov 27, 1979 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DYH/K792003

## Device Facts

- **Applicant:** Betta Dental, Inc.
- **Product Code:** [DYH](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DYH.md)
- **Decision Date:** Nov 27, 1979
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.3750
- **Device Class:** Class 2
- **Review Panel:** Dental

## Regulatory Identification

A bracket adhesive resin and tooth conditioner is a device composed of an adhesive compound, such as polymethylmethacrylate, intended to cement an orthodontic bracket to a tooth surface.

---

**Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DYH/K792003](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DYH/K792003)

**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