A mechanical device without adjustable parts intended to be placed between the teeth of the upper and lower jaws of a patient to maintain an open oral cavity, typically during emergent…
A mechanical device without adjustable parts intended to be placed between the teeth of the upper and lower jaws of a patient to maintain an open oral cavity, typically during emergent placement of an artificial airway or for an oral surgical intervention.
Who Else Makes It
Concentrated in Guangdong (1), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for Teeth Screw Driver | Listed by | Enter Medical Corporation, Taiwan |
| FDA product code | KBW |
| Device type | Screw, Oral |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2023-06-19 |
| Record revised | 2023-09-28 (version 2) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
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.