← Product Code [KMY](/submissions/DE/subpart-f%E2%80%94therapeutic-devices/KMY) · K891328

# PREFORMED TEMPLATE FOR TOOTH POSITIONER (K891328)

_American Orthodontics · KMY · Mar 31, 1989 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/KMY/K891328

## Device Facts

- **Applicant:** American Orthodontics
- **Product Code:** [KMY](/submissions/DE/subpart-f%E2%80%94therapeutic-devices/KMY.md)
- **Decision Date:** Mar 31, 1989
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.5525
- **Device Class:** Class 1
- **Review Panel:** Dental

## Regulatory Identification

A preformed tooth positioner is a plastic device that is an impression of a perfected bite intended to prevent a patient's teeth from shifting position or to move teeth to a final position after orthodontic appliances (braces) have been removed. The patient bites down on the device for several hours a day to force the teeth into a final position or to maintain the teeth in their corrected position.

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/KMY/K891328](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/KMY/K891328)

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