KMTClass I
Tray, Fluoride, Disposable
21 CFR 872.6870 / Dental
KMT is the FDA product code for Tray, Fluoride, Disposable, a class I device type, regulated under 21 CFR 872.6870. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- KMT
- Device name
- Tray, Fluoride, Disposable
- Regulation
- 21 CFR 872.6870
- Device class
- Class I
- Review panel
- Dental
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- Yes
- Third party review eligible
- No
- Ingested clearances
- 8
- Ingested recalls
- 0
Clearances, product code KMT
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1978 | 1 |
| 1981 | 1 |
| 1982 | 1 |
| 1985 | 1 |
| 1987 | 1 |
| 1990 | 1 |
| 2004 | 1 |
Applicants with the most clearances
Product code KMT| Applicant | Clearances |
|---|---|
| Colgate-Hoyt Laboratories | 1 |
| Hoyt Laboratories | 1 |
| Johnson & Johnson Professionals, Inc. | 1 |
| Kerr Corporation (Danbury) | 1 |
| Lorvic Corp. | 1 |
| Perio Protect LLC | 1 |
| Tang Products | 1 |
| The Lebanon Vac-Tray Corp. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- AMD Medicom Inc.
- Anqing Clean Dental Instrument Technology Co.,Ltd
- Bgss Company Asia Limited
- Buffalo Dental Mfg Co Inc
- Cargus Int'l, Inc.
- China Zhong Yan Chang Xing International Co. Ltd
- Coco International Trading Company Limited
- Creator Digital Dental Technology Co.Ltd
- Crosstex International, Inc.
- Den-Mat Holdings, LLC
- Dentimed Sao Joao
- Dharma Research/Medeco International
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
