K832662 is an FDA 510(k) clearance for the DENTAL SYRINGE SYSTEM-VARIOUS STYLES. This device is classified as a Applicator, Resin (Class I - General Controls, product code KXR).
Submitted by Centrix, Inc. (Walker, US). The FDA issued a Cleared decision on October 4, 1983, 57 days after receiving the submission on August 8, 1983.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3140.
| 510(k) Number | K832662 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 08, 1983 |
| Decision Date | October 04, 1983 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | KXR — Applicator, Resin |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.3140 |