The following data is part of a premarket notification filed by Beks Incorporated with the FDA for Britewhite Teeth Whitening System, Model Bw1101.
| Device ID | K063704 |
| 510k Number | K063704 |
| Device Name: | BRITEWHITE TEETH WHITENING SYSTEM, MODEL BW1101 |
| Classification | Heat Source For Bleaching Teeth |
| Applicant | BEKS INCORPORATED 694 BLUFF STREET # 104 Carol Stream, IL 60188 |
| Contact | Jill Creasy |
| Correspondent | Jill Creasy BEKS INCORPORATED 694 BLUFF STREET # 104 Carol Stream, IL 60188 |
| Product Code | EEG |
| CFR Regulation Number | 872.6475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-13 |
| Decision Date | 2007-02-20 |
| Summary: | summary |