Product code KMY
- Device name
- Positioner, Tooth, Preformed
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.5525
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K931615 | NITE-GUIDE | ORTHO-TAIN, Inc. | 1995-04-14 |
| K942667 | DENT-O-CRYL ORTHODONTIC ACRYLIC | Dentauraum, Inc. | 1995-02-13 |
| K924351 | GLENROE ELASTIBITE STIMULATOR | Glenroe Technologies | 1994-01-06 |
| K925064 | RELAX-O-GUARD | Aquatemp Service Co., Inc. | 1993-09-13 |
| K924975 | THE ORTHOTRAINER | Myofunctional Research Corp. Pty. , Ltd. | 1993-07-08 |
| K924974 | THE TMJ APPLIANCE | Myofunctional Research Corp. Pty. , Ltd. | 1993-06-23 |
| K904128 | PERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONER | American Orthodontics | 1990-11-09 |
| K891328 | PREFORMED TEMPLATE FOR TOOTH POSITIONER | American Orthodontics | 1989-03-31 |
| K833455 | REMOLDABLE CRANIOMANDIBULAR APPLIANCE | Jeffrey H. Attlin | 1984-01-10 |
| K831793 | AQUALIZER MOUTHPIECE | Martin D. Lerman | 1983-08-12 |
| K821458 | DYNAMIC FUNTIONAL POSITIONER | Dynamic Functional Positioner, Inc. | 1982-06-09 |
| K780619 | PREFORMED TOOTH POSITIONER | Tp Laboratories, Inc. | 1978-06-28 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08054154161263 | EQUILIBRATORE 1.2-S | EPTAMED SRL | 2026-08-27 |
| 08054154161614 | EQUILIBRATORE C2 | EPTAMED SRL | 2026-08-27 |
| 08054154161607 | EQUILIBRATORE C2 | EPTAMED SRL | 2026-08-27 |
| 08054154161591 | EQUILIBRATORE C2 | EPTAMED SRL | 2026-08-27 |
| 08054154161386 | EQUILIBRATORE 1.4-S | EPTAMED SRL | 2026-08-27 |
| 08054154161379 | EQUILIBRATORE 1.4-S | EPTAMED SRL | 2026-08-27 |
| 08054154161362 | EQUILIBRATORE 1.4 | EPTAMED SRL | 2026-08-27 |
| 08054154161355 | EQUILIBRATORE 1.4 | EPTAMED SRL | 2026-08-27 |
| 08054154161348 | EQUILIBRATORE 1.3-S | EPTAMED SRL | 2026-08-27 |
| 08054154161331 | EQUILIBRATORE 1.3-S | EPTAMED SRL | 2026-08-27 |
| 08054154161324 | EQUILIBRATORE 1.3-S | EPTAMED SRL | 2026-08-27 |
| 08054154161317 | EQUILIBRATORE 1.3-S | EPTAMED SRL | 2026-08-27 |
| 08054154161300 | EQUILIBRATORE 1.3 | EPTAMED SRL | 2026-08-27 |
| 08054154161294 | EQUILIBRATORE 1.3 | EPTAMED SRL | 2026-08-27 |
| 08054154161270 | EQUILIBRATORE 1.2-S | EPTAMED SRL | 2026-08-27 |
| 08054154160044 | EQUILIBRATORE 1.2 | EPTAMED SRL | 2026-08-27 |
| 08054154161256 | EQUILIBRATORE 1.2-S | EPTAMED SRL | 2026-08-27 |
| 08054154161249 | EQUILIBRATORE 1.2-S | EPTAMED SRL | 2026-08-27 |
| 08054154161232 | EQUILIBRATORE 1.2 | EPTAMED SRL | 2026-08-27 |
| 08054154161225 | EQUILIBRATORE 1.2 | EPTAMED SRL | 2026-08-27 |
| 08054154161218 | EQUILIBRATORE 1.2 | EPTAMED SRL | 2026-08-27 |
| 08054154161102 | EQUILIBRATORE 1.1 | EPTAMED SRL | 2026-08-27 |
| 08054154161096 | EQUILIBRATORE 1.1 | EPTAMED SRL | 2026-08-27 |
| 08054154161072 | EQUILIBRATORE 1.05 | EPTAMED SRL | 2026-08-27 |
| 08054154161065 | EQUILIBRATORE 1.05 | EPTAMED SRL | 2026-08-27 |
| 08054154161058 | EQUILIBRATORE 1.0 | EPTAMED SRL | 2026-08-27 |
| 08054154161041 | EQUILIBRATORE 1.0 | EPTAMED SRL | 2026-08-27 |
| 08054154160242 | EQUILIBRATORE C4P | EPTAMED SRL | 2026-08-27 |
| 08054154160082 | EQUILIBRATORE 1.4 | EPTAMED SRL | 2026-08-27 |
| 08054154160068 | EQULIBRATORE 1.3 | EPTAMED SRL | 2026-08-27 |