The following data is part of a premarket notification filed by Cosmetic Dental Materials Inc with the FDA for Quicksmile.
| Device ID | K052040 |
| 510k Number | K052040 |
| Device Name: | QUICKSMILE |
| Classification | Heat Source For Bleaching Teeth |
| Applicant | COSMETIC DENTAL MATERIALS INC 812 WATER ST. N.E. Albany, OR 97321 |
| Contact | Robert Bowers |
| Correspondent | Robert Bowers COSMETIC DENTAL MATERIALS INC 812 WATER ST. N.E. Albany, OR 97321 |
| Product Code | EEG |
| CFR Regulation Number | 872.6475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-28 |
| Decision Date | 2005-10-18 |
| Summary: | summary |