K890064 is an FDA 510(k) clearance for the DENTAL SYRINGE APPLICATION TIP. This device is classified as a Burnisher, Operative (Class I - General Controls, product code EKJ).
Submitted by Centrix, Inc. (Milford, US). The FDA issued a Cleared decision on February 10, 1989, 32 days after receiving the submission on January 9, 1989.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K890064 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 09, 1989 |
| Decision Date | February 10, 1989 |
| Days to Decision | 32 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 |