MONARCH II BLEACHING INSTRUMENT
Device Facts
| Record ID | K854692 |
|---|---|
| Device Name | MONARCH II BLEACHING INSTRUMENT |
| Applicant | Almore Intl., Inc. |
| Product Code | EEG · Dental |
| Decision Date | May 12, 1986 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.6475 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A heat source for bleaching teeth is an AC-powered device that consists of a light or an electric heater intended to apply heat to a tooth after it is treated with a bleaching agent.
