BRW · Protector, Dental
Anesthesiology · 21 CFR 868.5820 · Class 1
Overview
| Product Code | BRW |
|---|---|
| Device Name | Protector, Dental |
| Regulation | 21 CFR 868.5820 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
Identification
A dental protector is a device intended to protect a patient's teeth during manipulative procedures within a patient's oral cavity.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K945727 | CATCO NEONATAL PALATE GUARD | Catco Medical, Inc. | Dec 7, 1994 | SESE |
| K935713 | WILEY/ESPOSITO DENTAL GUARD | Fvtnks | Jan 5, 1994 | SESE |
| K851640 | TIP TOLEDO INCISOR PROTECTOR | Edward O. Goodwich | Sep 18, 1985 | SESE |
Top Applicants
- Catco Medical, Inc. — 1 clearance
- Edward O. Goodwich — 1 clearance
- Fvtnks — 1 clearance
