The following data is part of a premarket notification filed by Dentek Oral Care, Inc. with the FDA for Dentek Easy Brush With Fluoride.
| Device ID | K130186 |
| 510k Number | K130186 |
| Device Name: | DENTEK EASY BRUSH WITH FLUORIDE |
| Classification | Toothbrush, Manual |
| Applicant | DENTEK ORAL CARE, INC. 307 EXCELLENCE WAY Maryville, TN 37801 |
| Contact | Linda Giles |
| Correspondent | Linda Giles DENTEK ORAL CARE, INC. 307 EXCELLENCE WAY Maryville, TN 37801 |
| Product Code | EFW |
| CFR Regulation Number | 872.6855 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-25 |
| Decision Date | 2013-07-15 |
| Summary: | summary |