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 |
|---|---|---|---|
| 08054154160334 | EQUILIBRATORE NIKI 1 | EPTAMED SRL | 2026-07-28 |
| 08054154161164 | EQULIBRATORE U4 YOUNG | EPTAMED SRL | 2026-07-28 |
| 08054154161126 | EQUILIBRATORE C3P YOUNG | EPTAMED SRL | 2026-07-28 |
| 08054154161089 | EQULIBRATORE 1.1 | EPTAMED SRL | 2026-07-28 |
| 08054154160969 | EQUILIBRATORE U3 | EPTAMED SRL | 2026-07-28 |
| 08054154160945 | EQUILIBRATORE U3 | EPTAMED SRL | 2026-07-28 |
| 08054154160822 | EQUILIBRATORE GENIUS 2 | EPTAMED SRL | 2026-07-28 |
| 08054154160815 | EQUILIBRATORE GENIUS | EPTAMED SRL | 2026-07-28 |
| 08054154160761 | EQUILIBRATORE NIKI 2 | EPTAMED SRL | 2026-07-28 |
| 08054154160563 | EQUILIBRATORE GENIUS | EPTAMED SRL | 2026-07-28 |
| 08054154160501 | EQULIBRATORE U2 | EPTAMED SRL | 2026-07-28 |
| 08054154160433 | EQUILIBRATORE U4 | EPTAMED SRL | 2026-07-28 |
| 08054154160426 | EQUILIBRATORE U3 | EPTAMED SRL | 2026-07-28 |
| 08054154160402 | EQUILIBRATORE SL3 YOUNG | EPTAMED SRL | 2026-07-28 |
| 08054154160372 | EQUILIBRATORE 003 | EPTAMED SRL | 2026-07-28 |
| 08054154160013 | EQUILIBRATORE 1.0 | EPTAMED SRL | 2026-07-28 |
| 08054154160303 | EQUILIBRATORE GENIUS 3 | EPTAMED SRL | 2026-07-28 |
| 08054154160297 | FREEDOM | EPTAMED SRL | 2026-07-28 |
| 08054154160273 | EQUILIBRATORE E-FIT | EPTAMED SRL | 2026-07-28 |
| 08054154160266 | EQUILIBRATORE E-FIT | EPTAMED SRL | 2026-07-28 |
| 08054154160259 | EQUILIBRATORE E-FIT | EPTAMED SRL | 2026-07-28 |
| 08054154160228 | EQUILIBRATORE C3P | EPTAMED SRL | 2026-07-28 |
| 08054154160211 | Equilibratore C4 | EPTAMED SRL | 2026-07-28 |
| 08054154160204 | Equilibratore C3 | EPTAMED SRL | 2026-07-28 |
| 08054154160198 | EquiIlibratore C2 | EPTAMED SRL | 2026-07-28 |
| 08054154160150 | EQULIBRATORE 3.3 | EPTAMED SRL | 2026-07-28 |
| 08054154160143 | EQUILIBRATORE 3.2 | EPTAMED SRL | 2026-07-28 |
| 08054154160051 | EQUILIBRATORE 1.2 YOUNG | EPTAMED SRL | 2026-07-28 |
| 08054154160037 | EQUILIBRATORE 1.1 | EPTAMED SRL | 2026-07-28 |
| 08054154160020 | EQUILIBRATORE 1.05 | EPTAMED SRL | 2026-07-28 |