K834364 is an FDA 510(k) clearance for the CRYSTALLINE BONE SCREW ENDO-OSSEOUS. This device is classified as a Implant, Endosseous, Root-form (Class II - Special Controls, product code DZE).
Submitted by C.B.S. Biotechnics, Inc. (Walker, US). The FDA issued a Cleared decision on March 6, 1984, 131 days after receiving the submission on October 27, 1983.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3640.
| 510(k) Number | K834364 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 27, 1983 |
| Decision Date | March 06, 1984 |
| Days to Decision | 131 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 |