K863998 is an FDA 510(k) clearance for the COLTENE JET-MIXER. This device is classified as a Syringe, Restorative And Impression Material (Class I - General Controls, product code EID).
Submitted by Coltene, Inc. (Chicago, US). The FDA issued a Cleared decision on October 30, 1986, 16 days after receiving the submission on October 14, 1986.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K863998 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 14, 1986 |
| Decision Date | October 30, 1986 |
| Days to Decision | 16 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EID — Syringe, Restorative And Impression Material |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4565 |