K875339 is an FDA 510(k) clearance for the JETPOLISHER AIRPOLISHING POWDER. This device is classified as a Agent, Polishing, Abrasive, Oral Cavity (Class I - General Controls, product code EJR).
Submitted by Young Dental Manufacturing Co. 1, LLC (Maryland Heights, US). The FDA issued a Cleared decision on April 18, 1988, 110 days after receiving the submission on December 30, 1987.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6030.
| 510(k) Number | K875339 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 30, 1987 |
| Decision Date | April 18, 1988 |
| Days to Decision | 110 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | - |
| Product Code | EJR - Agent, Polishing, Abrasive, Oral Cavity |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.6030 |