Miscellaneous devices · 21 CFR 872 Subpart G
General Purpose Dental Tray
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
- Companies listing it
- 2620 makers
- Brands and models
- 23
- 510(k) clearances
- 00 in five years
- FDA name
- General Purpose Dental Tray
Companies that list OFX
26 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Dentsply Sirona, Inc. | United States | Maker | — | 148 | 2026 |
| Integra LifeSciences Corporation | United States | Maker | — | 2 | 2014 |
| Falcon Surgical Co. (Pvt.) Ltd. | Pakistan | Maker | General Purpose Dental Tray (Kit) | — | — |
| Shanghai Jolly Industrial Co., Ltd. | China | Maker | Endo bur holder/cleanser | — | — |
| Shanghai Lions Industrial Co., Ltd. | China | Maker | Endo bur holder/cleanser | — | — |
| TF New Material Sci and Tec Co.,ltd | China | Maker | Impression general dental tray | — | — |
| Medline Industries, LP | United States | Maker | Medline General Purpose Dental Tray | — | — |
| Henan Lusterdent Medical Instrument Co.,Ltd | China | Maker | Air Water Syringe Handpiece Unit / High Speed Dental Handpiece / Low Speed Dental Handpiece / · Dental Contra Angle Handpiece / Dental Straight Handpiece | — | — |
| CDM Center of Excellence Ltd. | China | Maker | General Purpose Dental Tray | — | — |
| Fabryka Narzedzi Medycznych CHIRMED Marcin Dyner Spolka Koma | Poland | Maker | General Purpose Dental Tray CHIRMED | — | — |
| Peter Brasseler Holdings, LLC | United States | Maker | Dental KIts | — | — |
| O&M Halyard, Inc. | United States | Maker | General Purpose Dental Tray · NICU Oral Care Kit · Oral Care Kit | — | — |
| Hubei Lanbin Medical Group Co., Ltd. | China | Maker | General Purpose Dental Tray - General Purpose Dental Tray | — | — |
| CeramTec Schweiz GmbH | Switzerland | Maker | Zeramex Dental Implant System | — | — |
| Ningbo Greetmed Medical Instruments Co., Ltd. | China | Maker | DENTAL TRAY | — | — |
| Fabtech Precision Sheet Metal, LLC | United States | Maker | Dental Cassette | — | — |
| Medsource Labs, LLC | United States | Maker | Dental Kit | — | — |
| Rademaker Medical Instruments | Netherlands | Maker | Crown Cassette | — | — |
| Cardinal Health 200, LLC | United States | Maker | — | — | — |
| Nichrominox SA | France | Maker | — | — | — |
| Tpc Advanced Technology, Inc. | United States | Repacker / relabeler | TPC Stainless Steel Dental Tray | 3 | 2007 |
| Sotera Health LLC | United States | Contract manufacturer | General purpose dental tray | — | — |
| STERIS Corporation | United States | Contract sterilizer | — | — | — |
| Midwest Sterilization Corp. | United States | Contract sterilizer | General purpose dental tray | — | — |
| DeRoyal Industries Inc | United States | Contract manufacturer | General Purpose Dental Tray - DeRoyal | — | — |
| Altitude Technologies, Inc DBA Chinook Medical Gear | United States | Repacker / relabeler | — | — | — |
Official records: FDA product classification for OFX · 21 CFR 872.6640.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026