KMY
12 FDA 510(k) clearances · Product code
252 daysmedian time to decision
496 days90th percentile
12clearances measured
FDA profile
- Official device name
- Positioner, Tooth, Preformed
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.5525
- Medical specialty
- Dental
- Adverse events (MAUDE)
- 2009: 3 · 2021: 71 · 2022: 19 · 2024: 376 · 2025: 459 · 2026: 713
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| NITE-GUIDE (K931615) | ORTHO-TAIN, Inc. | 1995-04-14 |
| DENT-O-CRYL ORTHODONTIC ACRYLIC (K942667) | Dentauraum, Inc. | 1995-02-13 |
| GLENROE ELASTIBITE STIMULATOR (K924351) | Glenroe Technologies | 1994-01-06 |
| RELAX-O-GUARD (K925064) | Aquatemp Service Co., Inc. | 1993-09-13 |
| THE ORTHOTRAINER (K924975) | Myofunctional Research Corp. Pty. , Ltd. | 1993-07-08 |
| THE TMJ APPLIANCE (K924974) | Myofunctional Research Corp. Pty. , Ltd. | 1993-06-23 |
| PERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONER (K904128) | American Orthodontics | 1990-11-09 |
| PREFORMED TEMPLATE FOR TOOTH POSITIONER (K891328) | American Orthodontics | 1989-03-31 |
| REMOLDABLE CRANIOMANDIBULAR APPLIANCE (K833455) | Jeffrey H. Attlin | 1984-01-10 |
| AQUALIZER MOUTHPIECE (K831793) | Martin D. Lerman | 1983-08-12 |
| DYNAMIC FUNTIONAL POSITIONER (K821458) | Dynamic Functional Positioner, Inc. | 1982-06-09 |
| PREFORMED TOOTH POSITIONER (K780619) | Tp Laboratories, Inc. | 1978-06-28 |
Track KMY automatically
Every clearance here is in the API, with alerts when new ones post.