K102308 is an FDA 510(k) clearance for the SIMPLELINE II MODEL SOFX483408R, SOFX483410R TOTAL 44 MODELS. This device is classified as a Implant, Endosseous, Root-form (Class II - Special Controls, product code DZE).
Submitted by Dentium Co., Ltd. (Cypress, US). The FDA issued a Cleared decision on November 22, 2010, 98 days after receiving the submission on August 16, 2010.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3640.
| 510(k) Number | K102308 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 16, 2010 |
| Decision Date | November 22, 2010 |
| Days to Decision | 98 days |
| Submission Type | Special |
| 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 |