FDA Product Code
FDA Product Code KMY — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.5525
510(k) Clearances — 12 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K931615 | NITE-GUIDE | ORTHO-TAIN, Inc. | 1995-04-14 | Traditional | PDF ↗ |
| K942667 | DENT-O-CRYL ORTHODONTIC ACRYLIC | Dentauraum, Inc. | 1995-02-13 | Traditional | PDF ↗ |
| K924351 | GLENROE ELASTIBITE STIMULATOR | Glenroe Technologies | 1994-01-06 | Traditional | PDF ↗ |
| K925064 | RELAX-O-GUARD | Aquatemp Service Co., Inc. | 1993-09-13 | Traditional | PDF ↗ |
| K924975 | THE ORTHOTRAINER | Myofunctional Research Corp. Pty. , Ltd. | 1993-07-08 | Traditional | PDF ↗ |
| K924974 | THE TMJ APPLIANCE | Myofunctional Research Corp. Pty. , Ltd. | 1993-06-23 | Traditional | PDF ↗ |
| K904128 | PERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONER | American Orthodontics | 1990-11-09 | Traditional | PDF ↗ |
| K891328 | PREFORMED TEMPLATE FOR TOOTH POSITIONER | American Orthodontics | 1989-03-31 | Traditional | PDF ↗ |
| K833455 | REMOLDABLE CRANIOMANDIBULAR APPLIANCE | Jeffrey H. Attlin | 1984-01-10 | Traditional | PDF ↗ |
| K831793 | AQUALIZER MOUTHPIECE | Martin D. Lerman | 1983-08-12 | Traditional | PDF ↗ |
| K821458 | DYNAMIC FUNTIONAL POSITIONER | Dynamic Functional Positioner, Inc. | 1982-06-09 | Traditional | PDF ↗ |
| K780619 | PREFORMED TOOTH POSITIONER | Tp Laboratories, Inc. | 1978-06-28 | Traditional | PDF ↗ |
Product code KMY · Class I · Dental. Data: openFDA.