K813227 is an FDA 510(k) clearance for the INTRAOSSEOUS DENTAL IMPLANT. This device is classified as a Implant, Endosseous, Root-form (Class II — Special Controls, product code DZE).
Submitted by Pacific Implant, Inc. (Walker, US). The FDA issued a Cleared decision on December 31, 1981, 51 days after receiving the submission on November 10, 1981.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3640.
| 510(k) Number | K813227 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 10, 1981 |
| Decision Date | December 31, 1981 |
| Days to Decision | 51 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | DZE — Implant, Endosseous, Root-form |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 872.3640 |