Single-use mouth protector intended for use during electroconvulsive therapy (ECT) to protect teeth and oral structures. Constructed from closed-cell foam and designed with an internal…
Single-use mouth protector intended for use during electroconvulsive therapy (ECT) to protect teeth and oral structures. Constructed from closed-cell foam and designed with an internal airway channel to allow airflow during use with anesthesia masks. Disposable design eliminates the need for cleaning and reduces the risk of cross-contamination.
Who Else Makes It
All of them in Guangdong. 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for Ventil-A Oral Protector | Listed by | Somatics, LLC, United States |
| FDA product code | JXL |
| Device type | Block, Bite |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5070 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K992269 |
| Record published | 2026-05-27 |
Specifications
Specifications | MRI safety | MR Safe |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.