K880590 is an FDA 510(k) clearance for the DISPOSABLE DENTAL PROBE/EXPLORER. This device is classified as a Burnisher, Operative (Class I - General Controls, product code EKJ).
Submitted by Baxter Healthcare Corp (Deerfield Lake, US). The FDA issued a Cleared decision on March 2, 1988, 20 days after receiving the submission on February 11, 1988.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K880590 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 11, 1988 |
| Decision Date | March 02, 1988 |
| Days to Decision | 20 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EKJ — Burnisher, Operative |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4565 |