The following data is part of a premarket notification filed by Homedics, Inc. with the FDA for Sonicwave Sonic Plaque Remover.
| Device ID | K012914 |
| 510k Number | K012914 |
| Device Name: | SONICWAVE SONIC PLAQUE REMOVER |
| Classification | Toothbrush, Powered |
| Applicant | HOMEDICS, INC. 3000 PONTIAC TRAIL Commerce Township, MI 48390 |
| Contact | David Vanderlin |
| Correspondent | David Vanderlin HOMEDICS, INC. 3000 PONTIAC TRAIL Commerce Township, MI 48390 |
| Product Code | JEQ |
| CFR Regulation Number | 872.6865 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-30 |
| Decision Date | 2001-10-01 |
| Summary: | summary |