FDA product code KMT: Tray, Fluoride, Disposable
KMT is the FDA product code for tray, fluoride, disposable. It is a Class I device, regulated under 21 CFR 872.6870 and reviewed by the Dental panel. FDA has cleared 8 510(k) submissions under KMT, from 8 different applicants. The average 510(k) review took 54 days (median 30).
Classification
| Field | Value |
|---|---|
| Device name | Tray, Fluoride, Disposable |
| Device class | Class I |
| Regulation | 21 CFR 872.6870 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every KMT clearance
Top KMT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Perio Protect, LLC | 1 | 2004-01-23 |
| The Lebanon Vac-Tray Corp. | 1 | 1990-12-17 |
| Colgate-Hoyt Laboratories | 1 | 1987-05-27 |
| Tang Products | 1 | 1985-11-18 |
| Johnson & Johnson Professionals, Inc. | 1 | 1982-02-23 |
3 more applicants have KMT clearances. See the full list in Caduvo.
Most recent KMT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K031809 | Perio Protect, LLC | PERIO PROTECT TRAY | 2004-01-23 | 225 |
| K904914 | The Lebanon Vac-Tray Corp. | DENTAL VACUUM INJECTION TRAY | 1990-12-17 | 47 |
| K871784 | Colgate-Hoyt Laboratories | TOP FORM II TRAYS, DISPOS FOAM-LINED TOP GEL APPLI | 1987-05-27 | 21 |
| K853882 | Tang Products | SUPER SLICK | 1985-11-18 | 60 |
| K820104 | Johnson & Johnson Professionals, Inc. | NUPRO* GEL TRAY | 1982-02-23 | 39 |
Recalls for KMT devices
openFDA lists no recalls for product code KMT.
Frequently asked questions
What is FDA product code KMT?
KMT is the FDA product code for tray, fluoride, disposable. It is a Class I device, regulated under 21 CFR 872.6870 and reviewed by the Dental panel.
What device class is KMT?
Class I, regulation 21 CFR 872.6870. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KMT?
Across 8 cleared submissions the average was 54 days from receipt to decision (median 30).
Which companies have the most KMT clearances?
Perio Protect, LLC (1); The Lebanon Vac-Tray Corp. (1); Colgate-Hoyt Laboratories (1); Tang Products (1); Johnson & Johnson Professionals, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KMT
- Run a recall and safety report across every KMT manufacturer
- Watch product code KMT 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.
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