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) → KMY — Positioner, Tooth, Preformed

# KMY · Positioner, Tooth, Preformed

_Dental · 21 CFR 872.5525 · Class 1_

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

## Overview

- **Product Code:** KMY
- **Device Name:** Positioner, Tooth, Preformed
- **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 (12 of 12)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K931615](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/KMY/K931615.md) | NITE-GUIDE | ORTHO-TAIN, Inc. | Apr 14, 1995 | SESE |
| [K942667](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/KMY/K942667.md) | DENT-O-CRYL ORTHODONTIC ACRYLIC | Dentauraum, Inc. | Feb 13, 1995 | SESE |
| [K924351](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/KMY/K924351.md) | GLENROE ELASTIBITE STIMULATOR | Glenroe Technologies | Jan 6, 1994 | SESE |
| [K925064](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/KMY/K925064.md) | RELAX-O-GUARD | Aquatemp Service Co., Inc. | Sep 13, 1993 | SN |
| [K924975](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/KMY/K924975.md) | THE ORTHOTRAINER | Myofunctional Research Corp. Pty. , Ltd. | Jul 8, 1993 | SESE |
| [K924974](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/KMY/K924974.md) | THE TMJ APPLIANCE | Myofunctional Research Corp. Pty. , Ltd. | Jun 23, 1993 | SN |
| [K904128](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/KMY/K904128.md) | PERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONER | American Orthodontics | Nov 9, 1990 | SESE |
| [K891328](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/KMY/K891328.md) | PREFORMED TEMPLATE FOR TOOTH POSITIONER | American Orthodontics | Mar 31, 1989 | SESE |
| [K833455](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/KMY/K833455.md) | REMOLDABLE CRANIOMANDIBULAR APPLIANCE | Jeffrey H. Attlin | Jan 10, 1984 | SESE |
| [K831793](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/KMY/K831793.md) | AQUALIZER MOUTHPIECE | Martin D. Lerman | Aug 12, 1983 | SESE |
| [K821458](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/KMY/K821458.md) | DYNAMIC FUNTIONAL POSITIONER | Dynamic Functional Positioner, Inc. | Jun 9, 1982 | SESE |
| [K780619](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/KMY/K780619.md) | PREFORMED TOOTH POSITIONER | Tp Laboratories, Inc. | Jun 28, 1978 | SESE |

## Top Applicants

- American Orthodontics — 2 clearances
- Myofunctional Research Corp. Pty. , Ltd. — 2 clearances
- Aquatemp Service Co., Inc. — 1 clearance
- Dentauraum, Inc. — 1 clearance
- Dynamic Functional Positioner, Inc. — 1 clearance

---

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

**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