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 |
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