K935561 is an FDA 510(k) clearance for the INTERPLAK HOME PLAQUE REMOVAL INSTRUMENT. This device is classified as a Toothbrush, Powered (Class I - General Controls, product code JEQ).
Submitted by Bausch & Lomb, Inc. (Tucker, US). The FDA issued a Cleared decision on January 26, 1994, 70 days after receiving the submission on November 17, 1993.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6865.
| 510(k) Number | K935561 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 17, 1993 |
| Decision Date | January 26, 1994 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | JEQ - Toothbrush, Powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.6865 |