K884533 is an FDA 510(k) clearance for the SENSODYNE SEALANT DENTIN CONDITIONING SYSTEM. This device is classified as a Agent, Tooth Bonding, Resin (Class II - Special Controls, product code KLE).
Submitted by Block Drug Company, Inc. (Jersey City, US). The FDA issued a Cleared decision on April 12, 1989, 166 days after receiving the submission on October 28, 1988.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3200.
| 510(k) Number | K884533 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 28, 1988 |
| Decision Date | April 12, 1989 |
| Days to Decision | 166 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | KLE — Agent, Tooth Bonding, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3200 |