Surgical devices · 21 CFR 872 Subpart E
Oral Surgery Tray
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf.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
- 1513 makers
- Brands and models
- 11
- 510(k) clearances
- 00 in five years
- FDA name
- Oral Surgery Tray
Companies that list PWL
15 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Osstem Implant Co., Ltd. | South Korea | Maker | Hiossen Basic Instrument KIT · Hiossen Simple Instrument KIT | 68 | 2026 |
| Shanghai Jolly Industrial Co., Ltd. | China | Maker | Mixing pad | — | — |
| Shanghai Lions Industrial Co., Ltd. | China | Maker | Mixing pad | — | — |
| Mident Ltd | United Kingdom | Maker | Oral Surgery Tray | — | — |
| Fabryka Narzedzi Medycznych CHIRMED Marcin Dyner Spolka Koma | Poland | Maker | Oral Surgery Tray CHIRMED | — | — |
| Cordica Medical (Formally Team Technologies, Inc) | United States | Maker | Mident Dental Trays | — | — |
| Robinson Healthcare Limited | United Kingdom | Maker | Instrapac | — | — |
| Hubei Lanbin Medical Group Co., Ltd. | China | Maker | Oral Surgery Tray - Oral Surgery Tray | — | — |
| Advanced Product Solutions Inc. | United States | Maker | Henry Schein · Invenio | — | — |
| Alleset, Inc. | United States | Maker | — | — | — |
| Cardinal Health 200, LLC | United States | Maker | — | — | — |
| Global Resources International Dominicana GRID S.R.L. | Dominican Republic | Maker | — | — | — |
| Invenio Alternate Care Solutions, LLC | United States | Maker | — | — | — |
| Sotera Health LLC | United States | Contract manufacturer | — | — | — |
| STERIS Corporation | United States | Contract sterilizer | — | — | — |
Official records: FDA product classification for PWL · 21 CFR 872.4565.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026