The following data is part of a premarket notification filed by Almore Intl., Inc. with the FDA for Monarch Ii Bleaching Instrument.
| Device ID | K854692 |
| 510k Number | K854692 |
| Device Name: | MONARCH II BLEACHING INSTRUMENT |
| Classification | Heat Source For Bleaching Teeth |
| Applicant | ALMORE INTL., INC. POST OFFICE BOX 25214 Portland, OR 97225 |
| Contact | Morin |
| Correspondent | Morin ALMORE INTL., INC. POST OFFICE BOX 25214 Portland, OR 97225 |
| Product Code | EEG |
| CFR Regulation Number | 872.6475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-21 |
| Decision Date | 1986-05-12 |