Data / Medical devices / Intraoral, Dental Foam Protector
Intraoral, Dental Foam Protector (PFL): 5 FDA-registered makers in 4 countries
5 establishments in 4 countries are registered with the FDA to make Intraoral, Dental Foam Protector (product code PFL, Class 1, 21 CFR 872.6890). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on September 30, 2013, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- PFL
- Device class
- 1
- Regulation
- 872.6890
- Medical specialty
- Dental
Makers by country
| Country | Makers |
|---|---|
| United States | 2 |
| Pakistan | 1 |
| China | 1 |
| South Korea | 1 |
Makers of Intraoral, Dental Foam Protector
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 |
|---|---|---|---|---|---|---|---|---|
| Artcraft Dental, Inc. | Austin, TX, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Falcon Surgical Co. (Pvt.) Ltd. | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Cooskin Stationery Co., Ltd | Ningbo Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| One Day Dental Partner | Suncheon-si Jeonnam, South Korea | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Reliance Orthodontic Products, Inc. | Itasca, IL, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 30, 2013. 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.