K964619 is an FDA 510(k) clearance for the DELIVERY SYSTEM(SDS 1400 XL)/DELIVERY SYSTEM CUSPIDOR(SDS1450,SDS1650 XL). This device is classified as a Unit, Operative Dental (Class I - General Controls, product code EIA).
Submitted by Sds Dental, Inc. (Fort Lauderdale, US). The FDA issued a Cleared decision on January 22, 1997, 65 days after receiving the submission on November 18, 1996.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6640.
| 510(k) Number | K964619 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 18, 1996 |
| Decision Date | January 22, 1997 |
| Days to Decision | 65 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EIA — Unit, Operative Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.6640 |