Data / Medical devices / Tray, Fluoride, Disposable
Tray, Fluoride, Disposable (KMT): 37 FDA-registered makers in 10 countries
37 establishments in 10 countries are registered with the FDA to make Tray, Fluoride, Disposable (product code KMT, Class 1, 21 CFR 872.6870). 2 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 8 510(k) clearances under this code, the latest on January 23, 2004, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- KMT
- Device class
- 1
- Regulation
- 872.6870
- Medical specialty
- Dental
Makers by country
| Country | Makers |
|---|---|
| China | 17 |
| United States | 11 |
| Germany | 2 |
| Canada | 1 |
| Hong Kong | 1 |
| Pakistan | 1 |
| South Korea | 1 |
| France | 1 |
| Turkey | 1 |
| India | 1 |
Makers of Tray, Fluoride, Disposable
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Ohlendorf Company | Affton, MO, United States | Manufacturer | 1 | January 23, 2004 | 0 | 0 | 0 | api.fda.gov |
| Perio Protect LLC | Saint Louis, MO, United States | Manufacturer | 1 | January 23, 2004 | 0 | 0 | 0 | api.fda.gov |
| AMD Medicom Inc. | Pointe-Claire, Montreal Quebec, Canada | Complaint file establishment, Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anqing Clean Dental Instrument Technology Co.,ltd | Anqing City Anhui, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BGSS Company Asia Limited | Zhabei Shanghai, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Buffalo Dental Mfg Co Inc | Hancock, NY, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| China Zhong Yan Chang Xing International Co. Ltd | Zibo City Shandong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Creator Digital Dental Technology Co.ltd | Zhuhai Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Crosstex International | Rush, NY, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Den-Mat Holdings, LLC | Lompoc, CA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Exceldent Dental Technology Development Co., Ltd. | Zhuhai Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| F-Six Dental Technology Co.,limited | Central Hong Kong, Hong Kong | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Forestadent Bernhard Forster GMBH | PFORZHEIM Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fseven Dental Technology Zhuhai Co.,ltd | ZHUHAI Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Falcon Surgical Co. (Pvt.) Ltd. | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Great Lakes Dental Technologies, Ltd. | Tonawanda, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hager & Werken GMBH | DUISBURG,DE-NOTA Hamburg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hdi Inc. | Seongnam-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Henan Baistra Medical Devices Limited | Zhengzhou Henan, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Huanghua Promisee Dental Co., Ltd | Huanghua Hebei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hydroral SAS | Acigne Bretagne, France | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Imicryl Dis Malzemeleri Sanayi Ve Ticaret A.S. | Konya, Turkey | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Inter-Med, Inc. | Racine, WI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jinyuan Medical Equipment(tianjin)co.,ltd | Tianjin, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kerr Corporation | Orange, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Keystone Industries | Myerstown, PA, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| M/S Leixir Resources Pvt. Ltd | GURUGRAM Haryana, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Practicon, Inc. | Greenville, NC, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Premium Plus (dongguan) Limited | Dongguan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Alwings Medical Instrument Co.,ltd. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Showcase Dental Lab LLC | Punta Gorda, FL, United States | Contract manufacturer, Contract sterilizer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sino-Vista Dental Instruments Co., Ltd. | Zibo Shandong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Pac-Dent Technology Co., Ltd | SUZHOU CITY Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tangshan Zhengtong Exhibition Co., Ltd. | Tangshan Hebei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhuhai Crystal Dental Technology Co.,ltd | Zhuhai Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ZOGEAR Medical Co., Ltd. | Yizheng Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| iBrite Suzhou Technology Co., Ltd | SUZHOU CITY Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 23, 2004. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.