K050871 is an FDA 510(k) clearance for the RIVA PROTECT. This device is classified as a Sealant, Pit And Fissure, And Conditioner (Class II - Special Controls, product code EBC).
Submitted by Southern Dental Industries, Inc. (Bayswater Vi 3125, AU). The FDA issued a Cleared decision on June 10, 2005, 65 days after receiving the submission on April 6, 2005.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3765.
| 510(k) Number | K050871 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 06, 2005 |
| Decision Date | June 10, 2005 |
| Days to Decision | 65 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EBC — Sealant, Pit And Fissure, And Conditioner |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3765 |