The following data is part of a premarket notification filed by Henry Schein, Inc. with the FDA for Schein Bleaching Unit.
| Device ID | K862385 |
| 510k Number | K862385 |
| Device Name: | SCHEIN BLEACHING UNIT |
| Classification | Heat Source For Bleaching Teeth |
| Applicant | HENRY SCHEIN, INC. 5 HARBOR PARK DR. Port Washington, NY 11050 |
| Contact | Michael J Mahr |
| Correspondent | Michael J Mahr HENRY SCHEIN, INC. 5 HARBOR PARK DR. Port Washington, NY 11050 |
| Product Code | EEG |
| CFR Regulation Number | 872.6475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-24 |
| Decision Date | 1986-10-30 |