The following data is part of a premarket notification filed by Pulpdent Corporation with the FDA for Spee-dee Patch.
| Device ID | K113617 |
| 510k Number | K113617 |
| Device Name: | SPEE-DEE PATCH |
| Classification | Material, Tooth Shade, Resin |
| Applicant | PULPDENT CORPORATION 80 Oakland St Watertown, MA 02472 |
| Contact | Kenneth J Berk |
| Correspondent | Kenneth J Berk PULPDENT CORPORATION 80 Oakland St Watertown, MA 02472 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-07 |
| Decision Date | 2012-03-02 |
| Summary: | summary |