The following data is part of a premarket notification filed by Oraline, Ltd. with the FDA for Oralspring Plus Battery-powered Toothbrush.
| Device ID | K941243 |
| 510k Number | K941243 |
| Device Name: | ORALSPRING PLUS BATTERY-POWERED TOOTHBRUSH |
| Classification | Toothbrush, Powered |
| Applicant | ORALINE, LTD. 7-B OLD COLONY DR. Westford, MA 01886 |
| Contact | James Marshall |
| Correspondent | James Marshall ORALINE, LTD. 7-B OLD COLONY DR. Westford, MA 01886 |
| Product Code | JEQ |
| CFR Regulation Number | 872.6865 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-15 |
| Decision Date | 1994-06-06 |