K130840 is an FDA 510(k) clearance for the SMARTBUILDER SYSTEM (SB1). This device is classified as a Plate, Bone (Class II - Special Controls, product code JEY).
Submitted by Osstem Implant Co., Ltd. (Fariless Hills, US). The FDA issued a Cleared decision on September 18, 2013, 175 days after receiving the submission on March 27, 2013.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4760.
| 510(k) Number | K130840 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 27, 2013 |
| Decision Date | September 18, 2013 |
| Days to Decision | 175 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | JEY — Plate, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4760 |