K960819 is an FDA 510(k) clearance for the HELIODENT DS. This device is classified as a Unit, X-ray, Intraoral (Class II - Special Controls, product code EAP).
Submitted by Pelton & Crane Co. (Charlotte, US). The FDA issued a Cleared decision on March 29, 1996, 29 days after receiving the submission on February 29, 1996.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 872.1810.
| 510(k) Number | K960819 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 29, 1996 |
| Decision Date | March 29, 1996 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | EAP — Unit, X-ray, Intraoral |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.1810 |