K033521 is an FDA 510(k) clearance for the BISBLOCK. This device is classified as a Liner, Cavity, Calcium Hydroxide (Class II - Special Controls, product code EJK).
Submitted by Bisco, Inc. (Schaumburg, US). The FDA issued a Cleared decision on January 16, 2004, 70 days after receiving the submission on November 7, 2003.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3250.
| 510(k) Number | K033521 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 07, 2003 |
| Decision Date | January 16, 2004 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EJK — Liner, Cavity, Calcium Hydroxide |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3250 |