K861581 is an FDA 510(k) clearance for the CENTRIX PCR MOLAR MATRIX FORMS (BANDS). This device is classified as a Instruments, Dental Hand (Class I - General Controls, product code DZN).
Submitted by Centrix, Inc. (Stratford, US). The FDA issued a Cleared decision on May 12, 1986, 13 days after receiving the submission on April 29, 1986.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K861581 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 29, 1986 |
| Decision Date | May 12, 1986 |
| Days to Decision | 13 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | DZN — Instruments, Dental Hand |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4565 |