DYT · Maintainer, Space Preformed, Orthodontic
Dental · 21 CFR 872.5525 · Class 1
Overview
| Product Code | DYT |
|---|---|
| Device Name | Maintainer, Space Preformed, Orthodontic |
| 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.
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K935856 | DENTAURUM SPACE MAINTAINER | Dentauraum, Inc. | Apr 28, 1994 | SESE |
| K864376 | FIBERBOND | Dentec, Inc. | Apr 7, 1987 | SESE |
| K812239 | UNITEK PALATAL BAR | Unitek Corp. | Sep 21, 1981 | SESE |
| K780814 | SAFETY STOP NECKSTRAP | Northwest Orthodontics, Inc. | Jun 30, 1978 | SESE |
Top Applicants
- Unitek Corp. — 1 clearance
- Northwest Orthodontics, Inc. — 1 clearance
- Dentec, Inc. — 1 clearance
- Dentauraum, Inc. — 1 clearance
