Miscellaneous devices · 21 CFR 872 Subpart G
Dental Foam Protector Intraoral
Intended to provide a soft barrier between wired mouth hardware and oral mucosa.
- Companies listing it
- 55 makers
- Brands and models
- 5
- 510(k) clearances
- 10 in five years
- FDA name
- Intraoral, Dental Foam Protector
510(k) clearances per year, 1976–2026
Companies that list PFL
5 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Reliance Orthodontic Products, Inc. | United States | Maker | ReliaBites | 32 | 2021 |
| Falcon Surgical Co. (Pvt.) Ltd. | Pakistan | Maker | Intraoral, dental foam protector | — | — |
| ArtCraft Dental, Inc. | United States | Maker | Crown Gripps | — | — |
| Ningbo Cooskin Stationery Co., Ltd. | China | Maker | Toothpaste | — | — |
| one day dental partner | South Korea | Maker | kage intraoral protect | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 30 Sep 2013 | K131396 | WIRED MOUTH PROTECTOR (WMP) | Elba Laboratories, Inc. |
Official records: FDA product classification for PFL · 21 CFR 872.6890.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026