K921601 is an FDA 510(k) clearance for the ULTRADENT PROD RETRACT CORD/ACCESSORY PRODUCT LINE. This device is classified as a Floss, Dental (Class I - General Controls, product code JES).
Submitted by Ultradent Products, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on June 16, 1992, 74 days after receiving the submission on April 3, 1992.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6390.
| 510(k) Number | K921601 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 03, 1992 |
| Decision Date | June 16, 1992 |
| Days to Decision | 74 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 |