K002168 is an FDA 510(k) clearance for the ASPIJECT SELF-ASPIRATING DENTAL INJECTION SYRINGE. This device is classified as a Syringe, Cartridge (Class II - Special Controls, product code EJI).
Submitted by Ronvig Instruments, Ltd. (Dk-8721 Daugaard, DK). The FDA issued a Cleared decision on October 13, 2000, 88 days after receiving the submission on July 17, 2000.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6770.
| 510(k) Number | K002168 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 17, 2000 |
| Decision Date | October 13, 2000 |
| Days to Decision | 88 days |
| Submission Type | Abbreviated |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EJI — Syringe, Cartridge |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.6770 |