K041655 is an FDA 510(k) clearance for the BIO PLANT SYSTEM (IMPLANTS AND ABUTMENTS). This device is classified as a Implant, Endosseous, Root-form (Class II - Special Controls, product code DZE).
Submitted by Cowellmedi Co., Ltd. (Newington, US). The FDA issued a Cleared decision on September 8, 2004, 82 days after receiving the submission on June 18, 2004.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3640.
| 510(k) Number | K041655 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 18, 2004 |
| Decision Date | September 08, 2004 |
| Days to Decision | 82 days |
| Submission Type | Abbreviated |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | DZE - Implant, Endosseous, Root-form |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3640 |