FDA product code KMY: Positioner, Tooth, Preformed
KMY is the FDA product code for positioner, tooth, preformed. It is a Class I device, regulated under 21 CFR 872.5525 and reviewed by the Dental panel. FDA has cleared 12 510(k) submissions under KMY, from 10 different applicants. The average 510(k) review took 229 days (median 178).
Classification
| Field | Value |
|---|---|
| Device name | Positioner, Tooth, Preformed |
| Device class | Class I |
| Regulation | 21 CFR 872.5525 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KMY clearance
Top KMY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Myofunctional Research Corp. Pty. , Ltd. | 2 | 1993-07-08 |
| American Orthodontics | 2 | 1990-11-09 |
| ORTHO-TAIN, Inc. | 1 | 1995-04-14 |
| Dentauraum, Inc. | 1 | 1995-02-13 |
| Glenroe Technologies | 1 | 1994-01-06 |
5 more applicants have KMY clearances. See the full list in Caduvo.
Most recent KMY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K931615 | ORTHO-TAIN, Inc. | NITE-GUIDE | 1995-04-14 | 743 |
| K942667 | Dentauraum, Inc. | DENT-O-CRYL ORTHODONTIC ACRYLIC | 1995-02-13 | 252 |
| K924351 | Glenroe Technologies | GLENROE ELASTIBITE STIMULATOR | 1994-01-06 | 496 |
| K925064 | Aquatemp Service Co., Inc. | RELAX-O-GUARD | 1993-09-13 | 342 |
| K924975 | Myofunctional Research Corp. Pty. , Ltd. | THE ORTHOTRAINER | 1993-07-08 | 281 |
Recalls for KMY devices
openFDA lists no recalls for product code KMY.
Frequently asked questions
What is FDA product code KMY?
KMY is the FDA product code for positioner, tooth, preformed. It is a Class I device, regulated under 21 CFR 872.5525 and reviewed by the Dental panel.
What device class is KMY?
Class I, regulation 21 CFR 872.5525. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KMY?
Across 12 cleared submissions the average was 229 days from receipt to decision (median 178).
Which companies have the most KMY clearances?
Myofunctional Research Corp. Pty. , Ltd. (2); American Orthodontics (2); ORTHO-TAIN, Inc. (1); Dentauraum, Inc. (1); Glenroe Technologies (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KMY
- Run a recall and safety report across every KMY manufacturer
- Watch product code KMY for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Dental product codes · FDA product code lookup · 510(k) database search · 510(k) review times