K935522 is an FDA 510(k) clearance for the RANIR DENTAL TAPE MINT WAXED WITH FLOURIDE. This device is classified as a Floss, Dental (Class I - General Controls, product code JES).
Submitted by Ranir/Dcp Corp. (Grand Rapids, US). The FDA issued a Cleared decision on January 26, 1994, 71 days after receiving the submission on November 16, 1993.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6390.
| 510(k) Number | K935522 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 16, 1993 |
| Decision Date | January 26, 1994 |
| Days to Decision | 71 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | JES — Floss, Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.6390 |