Positioner, Tooth, Preformed
FDA product code KMY · Class I (low risk) · 21 CFR 872.5525 · Dental
12510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K931615 | Nite-GuideKMY · Traditional | ORTHO-TAIN, Inc. | 04/14/1995SE |
| K942667 | Dent-O-Cryl Orthodontic AcrylicKMY · Traditional | Dentauraum, Inc. | 02/13/1995SE |
| K924351 | Glenroe Elastibite StimulatorKMY · Traditional | Glenroe Technologies | 01/06/1994SE |
| K925064 | Relax-O-GuardKMY · Traditional | Aquatemp Service Co., Inc. | 09/13/1993SN |
| K924975 | The OrthotrainerKMY · Traditional | Myofunctional Research Corp. Pty. , Ltd. | 07/08/1993SE |
| K924974 | The TMJ ApplianceKMY · Traditional | Myofunctional Research Corp. Pty. , Ltd. | 06/23/1993SN |
| K904128 | Performed Template W/Fragrance for Tooth PostionerKMY · Traditional | American Orthodontics | 11/09/1990SE |
| K891328 | Preformed Template for Tooth PositionerKMY · Traditional | American Orthodontics | 03/31/1989SE |
| K833455 | Remoldable Craniomandibular ApplianceKMY · Traditional | Jeffrey H. Attlin | 01/10/1984SE |
| K831793 | Aqualizer MouthpieceKMY · Traditional | Martin D. Lerman | 08/12/1983SE |
| K821458 | Dynamic Funtional PositionerKMY · Traditional | Dynamic Functional Positioner, Inc. | 06/09/1982SE |
| K780619 | Preformed Tooth PositionerKMY · Traditional | Tp Laboratories, Inc. | 06/28/1978SE |