Protector, Dental
The Protector, Dental is a device used in anesthesiology settings to protect a patient's teeth from damage during airway management procedures such as intubation. It is classified as FDA Class 1, the lowest risk category, subject to general controls only and exempt from premarket notification. The product code is BRW, regulated under 21 CFR 868.5820 within the Anesthesiology medical specialty.
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Basic Information
- Product Code
- BRW
- Device Class
- FDA class 1
- Regulation Number
- 868.5820
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K945727 | CATCO NEONATAL PALATE GUARD | Dec 07, 1994 | Substantially Equivalent | Catco Medical, Inc. |
| K935713 | WILEY/ESPOSITO DENTAL GUARD | Jan 05, 1994 | Substantially Equivalent | Fvtnks |
| K851640 | TIP TOLEDO INCISOR PROTECTOR | Sep 18, 1985 | Substantially Equivalent | Edward O. Goodwich |
FEI Numbers
This FDA classification entry is associated with 72 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 72 registration numbers. Click on an entry to view related FDA registrations.