K940260 is an FDA 510(k) clearance for the THERMAL PULP TESTER. This device is classified as a Tester, Pulp (Class II - Special Controls, product code EAT).
Submitted by Union Broach, Div. Moyco Industries, Inc. (Philadelphia, US). The FDA issued a Cleared decision on March 7, 1994, 45 days after receiving the submission on January 21, 1994.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.1720.
| 510(k) Number | K940260 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 21, 1994 |
| Decision Date | March 07, 1994 |
| Days to Decision | 45 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EAT — Tester, Pulp |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.1720 |