K190043 is an FDA 510(k) clearance for the Halley resin. This device is classified as a Resin, Denture, Relining, Repairing, Rebasing (Class II - Special Controls, product code EBI).
Submitted by Dentsply Sirona (York, US). The FDA issued a Cleared decision on April 24, 2019, 105 days after receiving the submission on January 9, 2019.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3760.
| 510(k) Number | K190043 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 09, 2019 |
| Decision Date | April 24, 2019 |
| Days to Decision | 105 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EBI — Resin, Denture, Relining, Repairing, Rebasing |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3760 |