K864376 is an FDA 510(k) clearance for the FIBERBOND. This device is classified as a Maintainer, Space Preformed, Orthodontic (Class I - General Controls, product code DYT).
Submitted by Dentec, Inc. (Roslyn, US). The FDA issued a Cleared decision on April 7, 1987, 153 days after receiving the submission on November 5, 1986.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5525.
| 510(k) Number | K864376 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 05, 1986 |
| Decision Date | April 07, 1987 |
| Days to Decision | 153 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | DYT — Maintainer, Space Preformed, Orthodontic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.5525 |