K931137 is an FDA 510(k) clearance for the DENTAL SYRINGE TIP. This device is classified as a Unit, Syringe, Air And/or Water (Class I - General Controls, product code ECB).
Submitted by A-Dec, Inc. (Newberg, US). The FDA issued a Cleared decision on November 29, 1993, 269 days after receiving the submission on March 5, 1993.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K931137 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 05, 1993 |
| Decision Date | November 29, 1993 |
| Days to Decision | 269 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | ECB — Unit, Syringe, Air And/or Water |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4565 |