The following data is part of a premarket notification filed by Cooper Care, Inc. with the FDA for Sanodent Double-ended Interdental Clean.
| Device ID | K832949 |
| 510k Number | K832949 |
| Device Name: | SANODENT DOUBLE-ENDED INTERDENTAL CLEAN |
| Classification | Pick, Massaging |
| Applicant | COOPER CARE, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JET |
| CFR Regulation Number | 872.6650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-02 |
| Decision Date | 1983-10-04 |