← Product Code [DYH](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DYH) · K941015

# ORMCO SYSTEM 1+ (TM) (K941015)

_Ormco Corp. · DYH · Mar 31, 1994 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DYH/K941015

## Device Facts

- **Applicant:** Ormco Corp.
- **Product Code:** [DYH](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DYH.md)
- **Decision Date:** Mar 31, 1994
- **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.

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DYH/K941015](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DYH/K941015)

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