Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart F — Therapeutic Devices](/submissions/DE/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 872.5525](/submissions/DE/subpart-f%E2%80%94therapeutic-devices/872.5525) → DYT — Maintainer, Space Preformed, Orthodontic

# DYT · Maintainer, Space Preformed, Orthodontic

_Dental · 21 CFR 872.5525 · Class 1_

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

## Overview

- **Product Code:** DYT
- **Device Name:** Maintainer, Space Preformed, Orthodontic
- **Regulation:** [21 CFR 872.5525](/submissions/DE/subpart-f%E2%80%94therapeutic-devices/872.5525)
- **Device Class:** 1
- **Review Panel:** [Dental](/submissions/DE)

## 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.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

## Recent Cleared Devices (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K935856](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/DYT/K935856.md) | DENTAURUM SPACE MAINTAINER | Dentauraum, Inc. | Apr 28, 1994 | SESE |
| [K864376](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/DYT/K864376.md) | FIBERBOND | Dentec, Inc. | Apr 7, 1987 | SESE |
| [K812239](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/DYT/K812239.md) | UNITEK PALATAL BAR | Unitek Corp. | Sep 21, 1981 | SESE |
| [K780814](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/DYT/K780814.md) | SAFETY STOP NECKSTRAP | Northwest Orthodontics, Inc. | Jun 30, 1978 | SESE |

## Top Applicants

- Dentauraum, Inc. — 1 clearance
- Dentec, Inc. — 1 clearance
- Northwest Orthodontics, Inc. — 1 clearance
- Unitek Corp. — 1 clearance

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

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