KMY · Positioner, Tooth, Preformed
Dental · 21 CFR 872.5525 · Class 1
Overview
| Product Code | KMY |
|---|---|
| Device Name | Positioner, Tooth, Preformed |
| Regulation | 21 CFR 872.5525 |
| Device Class | Class 1 |
| Review Panel | Dental |
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.
Cleared Devices (12)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K931615 | NITE-GUIDE | ORTHO-TAIN, Inc. | Apr 14, 1995 | SESE |
| K942667 | DENT-O-CRYL ORTHODONTIC ACRYLIC | Dentauraum, Inc. | Feb 13, 1995 | SESE |
| K924351 | GLENROE ELASTIBITE STIMULATOR | Glenroe Technologies | Jan 6, 1994 | SESE |
| K925064 | RELAX-O-GUARD | Aquatemp Service Co., Inc. | Sep 13, 1993 | SN |
| K924975 | THE ORTHOTRAINER | Myofunctional Research Corp. Pty. , Ltd. | Jul 8, 1993 | SESE |
| K924974 | THE TMJ APPLIANCE | Myofunctional Research Corp. Pty. , Ltd. | Jun 23, 1993 | SN |
| K904128 | PERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONER | American Orthodontics | Nov 9, 1990 | SESE |
| K891328 | PREFORMED TEMPLATE FOR TOOTH POSITIONER | American Orthodontics | Mar 31, 1989 | SESE |
| K833455 | REMOLDABLE CRANIOMANDIBULAR APPLIANCE | Jeffrey H. Attlin | Jan 10, 1984 | SESE |
| K831793 | AQUALIZER MOUTHPIECE | Martin D. Lerman | Aug 12, 1983 | SESE |
| K821458 | DYNAMIC FUNTIONAL POSITIONER | Dynamic Functional Positioner, Inc. | Jun 9, 1982 | SESE |
| K780619 | PREFORMED TOOTH POSITIONER | Tp Laboratories, Inc. | Jun 28, 1978 | SESE |
Top Applicants
- Myofunctional Research Corp. Pty. , Ltd. — 2 clearances
- American Orthodontics — 2 clearances
- Tp Laboratories, Inc. — 1 clearance
- ORTHO-TAIN, Inc. — 1 clearance
- Martin D. Lerman — 1 clearance
