The following data is part of a premarket notification filed by Britesmile, Inc. with the FDA for Britesmile Barrier Material.
| Device ID | K010935 |
| 510k Number | K010935 |
| Device Name: | BRITESMILE BARRIER MATERIAL |
| Classification | Dam, Rubber |
| Applicant | BRITESMILE, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Sheila Hemeon-heyer |
| Correspondent | Sheila Hemeon-heyer BRITESMILE, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | EIE |
| CFR Regulation Number | 872.6300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-28 |
| Decision Date | 2001-09-05 |