Miscellaneous devices · 21 CFR 872 Subpart G
Disposable Fluoride Tray
FDA device type “Tray, Fluoride, Disposable”.
- Companies listing it
- 6034 makers
- Brands and models
- 70
- 510(k) clearances
- 80 in five years
- FDA name
- Tray, Fluoride, Disposable
510(k) clearances per year, 1976–2026
Companies that list KMT
60 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Sybron Dental Specialties | United States | Maker | Discovery Trays | 203 | 2026 |
| Inter-Med, Inc. | United States | Maker | Fluoride Tray | 7 | 2026 |
| Den-Mat Holdings, LLC | United States | Maker | Perio Tray | 8 | 2026 |
| Pac-Dent Inc. | United States | Maker | Pac-Dent Disposable Tray, Tooth Whitening | 5 | 2022 |
| Imicryl Dis Malzemeleri Sanayi VE Ticaret AS | Türkiye | Maker | IMITRAY, POLIMO Fluoride Trays | 5 | 2022 |
| Keystone Industries | United States | Maker | Gelato Disposable Fluoride Trays · Keystone Industries Disposable Fluoride Trays · Mizzy Prevent Fluoride Trays | 2 | 2025 |
| Premium Plus (Dongguan) Limited | China | Maker | Fluoride trays | 2 | 2025 |
| HDI Inc. | South Korea | Maker | Denu Fluoride Gel Tray | 2 | 2022 |
| Buffalo Dental Mfg. Co., Inc. | United States | Maker | Disposable Fluoride Trays, Vacuum Forming Materials | 11 | 1996 |
| Forestadent Bernhard Forster GmbH | Germany | Maker | — | 4 | 2011 |
| Perio Protect, LLC | United States | Maker | Perio Tray | 1 | 2004 |
| Practicon, Inc. | United States | Maker | I-Beam Fluoride Tray | — | — |
| Huanghua Promisee Dental Co., Ltd | China | Maker | Disposable Fluoride Tray | — | — |
| Falcon Surgical Co. (Pvt.) Ltd. | Pakistan | Maker | TRAY, FLUORIDE, DISPOSABLE | — | — |
| Shanghai Alwings Medical Instrument Co.,Ltd. | China | Maker | Fluoride Foam Tray | — | — |
| Great Lakes Dental Technologies, Ltd. | United States | Maker | PERIO PROTECT TRAY · PERIO TRAY | — | — |
| Tangshan Zhengtong Exhibition Co., Ltd. | China | Maker | Disposable Fluoride Foam Trays | — | — |
| ZOGEAR Medical Co., Ltd. | China | Maker | Dental Disposable Fluoride Tray | — | — |
| Anqing Clean Dental Instrument Technology Co Ltd | China | Maker | dental fluoride trays · TRAY, FLUORIDE, DISPOSABLE/Medicom Disposable Gel Tray | — | — |
| AMD Medicom Inc | Canada | Maker | Medicom Disposable Gel Tray | — | — |
| Henan Baistra Medical Devices Limited | China | Maker | TRAY, FLUORIDE, DISPOSABLE | — | — |
| Hager & Werken | Germany | Maker | RFECT PLAST KIT | — | — |
| Jinyuan medical equipment(tianjin)co.,ltd | China | Maker | Disposable Impression Tray/ Bite Registration Tray/ Fluoride Impression Tray/ Bite Whitening Tray | — | — |
| Fseven Dental Technology Zhuhai Co.,ltd | China | Maker | Perio Tray | — | — |
| Leixir Resources Private Limited | India | Maker | Bleaching Tray | — | — |
| Showcase Dental Lab LLC | United States | Maker | Bleaching Tray · Dental Product | — | — |
| EXCELDENT Dental Technology Development Co., Ltd. | China | Maker | TRAY,FLUORIDE,DISPOSABLE | — | — |
| F-Six Dental Technology Co.,limited | Hong Kong SAR China | Maker | Perio Tray | — | — |
| China Zhong Yan Chang ING International Co, LTD | China | Maker | Tay, Fluoride | — | — |
| Ohlendorf Company | United States | Maker | Perio Protect Tray | — | — |
| BGSS Company Asia Limited | China | Maker | — | — | — |
| Zhuhai Crystal Dental Technology Co.,Ltd | China | Maker | PERIO TRAY | — | — |
| Creator Digital Dental Technology Co.LTD | China | Maker | Perio Tray | — | — |
| HydrOral SAS | France | Maker | Hydroral PDA | — | — |
| Young Innovations Inc | United States | Contract manufacturer | Fluoride Trays · Oral-B Centrays Disposable Fluoride Applicator Trays · Oral-B Centwins Disposable Fluoride Applicator Trays | 23 | 2025 |
| Lakong Medical Devices Co., Ltd. | China | Foreign exporter | Fluoride Tray, Disposable | 2 | 2026 |
| Essential Dental Systems, Inc. | United States | Repacker / relabeler | — | 15 | 2023 |
| DSI Dental Solutions Ltd | Israel | Manufacturer | Fluoride Gel Tray | 2 | 2025 |
| Premium Plus International Limited | Hong Kong SAR China | Foreign exporter | Dentmas · 7800 Fluoride Trays · 7801 Fluoride Trays | 3 | 2017 |
| Tpc Advanced Technology, Inc. | United States | Repacker / relabeler | TPC Disposable Fluoride Tray | 3 | 2007 |
| Dharma Research, Inc. | United States | Contract manufacturer | ADS Fluoride Trays · Ionite Fluoride Trays · Sherbet Fluoride Trays | 1 | 2015 |
| One Dashcorp | United States | Repacker / relabeler | Valdent USA Blue Disposable Fluoride Foam Trays, Large · Valdent USA Green Disposable Fluoride Foam Trays, Small · Valdent USA Yellow Disposable Fluoride Foam Trays, Medium | — | — |
| Wuxi Lyusmile Imp and Exp Co.,ltd | China | Private-label distributor | FLUORIDE FOAM TRAY | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | ANGELUS | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | TRAY, FLUORIDE, DISPOSABLE | — | — |
| Premium Plus Dental | United States | Lister | Premium Plus Dluoride Trays Disposable | — | — |
| SPS/Crosstex International | United States | Manufacturer | ZAP Dual Arch Fluoride Gel Trays | — | — |
| Pascal International | United States | Contract manufacturer | Juciy Tray · Juicy Tray Animal Pals · PDP Foam Fluoride Tray | — | — |
| Yizur Ltd | Hong Kong SAR China | Foreign exporter | TRAY, FLUORIDE, DISPOSABLE | — | — |
| CARGUS International Inc. | United States | Repacker / relabeler | Cargus Fluoride Trays · MARK3® Fluoride Trays | — | — |
| READY SET IMPORT dba Mynt Professional | United States | Repacker / relabeler | RSI Disposable Fluoride Tray | — | — |
| Maxill Inc. | United States | Foreign exporter | Maxill | — | — |
| Dukal Corporation | United States | Specification developer | Unipack Fluoride Trays | — | — |
| Shanghai Hua EN Industrial Co. Ltd. | China | Foreign exporter | UniPack | — | — |
| Northstar Trade Co., Limited | China | Foreign exporter | — | — | — |
| Ryder Integrated Logistics, INC | United States | Repacker / relabeler | — | — | — |
| Coco International Trading Company Limited | Hong Kong SAR China | Foreign exporter | PERIO TRAY | — | — |
| Natural Dental Laboratory Co.,limited | China | Foreign exporter | Perio Tray | — | — |
| Shimmer Trade Company Limited | Hong Kong SAR China | Foreign exporter | TRAY, FLUORIDE,DISPOSABLE | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 23 Jan 2004 | K031809 | PERIO PROTECT TRAY | Perio Protect, LLC |
| 17 Dec 1990 | K904914 | DENTAL VACUUM INJECTION TRAY | The Lebanon Vac-Tray Corp. |
| 27 May 1987 | K871784 | TOP FORM II TRAYS, DISPOS FOAM-LINED TOP GEL APPLI | Colgate-Hoyt Laboratories |
| 18 Nov 1985 | K853882 | SUPER SLICK | Tang Products |
| 23 Feb 1982 | K820104 | NUPRO* GEL TRAY | Johnson & Johnson Professionals, Inc. |
| 13 May 1981 | K811154 | HOYT ECONO-TRAY | Hoyt Laboratories |
| 17 May 1978 | K780712 | KERR DISCOVERY DISPOSABLE FLUORIDE TRAY | Kerr Corporation (Danbury) |
| 14 Jan 1977 | K770064 | FLUORIDE GEL DISPOSABLE TRAY | Lorvic Corp. |
Official records: FDA product classification for KMT · 21 CFR 872.6870.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026