K861239 is an FDA 510(k) clearance for the ACRYLIC SOLDER. This device is classified as a Resin, Denture, Relining, Repairing, Rebasing (Class II - Special Controls, product code EBI).
Submitted by Parker Laboratories, Inc. (Farmingdale, US). The FDA issued a Cleared decision on April 17, 1986, 15 days after receiving the submission on April 2, 1986.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3760.
| 510(k) Number | K861239 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 02, 1986 |
| Decision Date | April 17, 1986 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EBI — Resin, Denture, Relining, Repairing, Rebasing |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3760 |