Data / Medical devices / Oral Surgery Tray
Oral Surgery Tray (PWL): 14 FDA-registered makers in 7 countries
14 establishments in 7 countries are registered with the FDA to make Oral Surgery Tray (product code PWL, Class 1, 21 CFR 872.4565). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- PWL
- Device class
- 1
- Regulation
- 872.4565
- Medical specialty
- Dental
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| China | 3 |
| United Kingdom | 2 |
| Mexico | 1 |
| Poland | 1 |
| Dominican Republic | 1 |
| South Korea | 1 |
Makers of Oral Surgery Tray
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 |
|---|---|---|---|---|---|---|---|---|
| Advanced Product Solutions Inc. | Dothan, AL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cordica Medical, Inc. | Morristown, TN, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cardinal Health 200, LLC | El Paso, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Convertors de Mexico S. de R.L. de C.V | CD.JUAREZ Chihuahua, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fabryka Narzedzi Medycznych CHIRMED Marcin Dyner Spolka Komandytowa | RUDNIKI K/CZESTOCHOWY Slaskie, Poland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Global Resources International Dominicana Grid S.R.L. | San Pedro de Macoris, Dominican Republic | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GRI-Alleset, Inc. | Flowery Branch, GA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hubei Lanbin Medical Group Co., Ltd. | Xiaogan City Hubei, China | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Invenio Alternate Care Solutions, LLC | Peachtree Corners, GA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nova Instruments | Berkshire Wokingham, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Osstem Implant Co., Ltd. | Gangseo-gu Seoul, South Korea | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Robinson Healthcare Limited | Worksop Nottinghamshire, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Lions Industrial Co.,ltd. | Shanghai, China | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai, China | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.