The following data is part of a premarket notification filed by Osstem Implant Co.,ltd with the FDA for Smartbuilder System (sb1).
| Device ID | K130840 |
| 510k Number | K130840 |
| Device Name: | SMARTBUILDER SYSTEM (SB1) |
| Classification | Plate, Bone |
| Applicant | OSSTEM IMPLANT CO.,LTD 85 BEN FAIRLESS DR. Fairless Hills, PA 19030 |
| Contact | Patrick Lim |
| Correspondent | Patrick Lim OSSTEM IMPLANT CO.,LTD 85 BEN FAIRLESS DR. Fairless Hills, PA 19030 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-27 |
| Decision Date | 2013-09-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800000925233 | K130840 | 000 |
| 08800000925134 | K130840 | 000 |
| 08800000925141 | K130840 | 000 |
| 08800000925158 | K130840 | 000 |
| 08800000925165 | K130840 | 000 |
| 08800000925172 | K130840 | 000 |
| 08800000925189 | K130840 | 000 |
| 08800000925196 | K130840 | 000 |
| 08800000925202 | K130840 | 000 |
| 08800000925219 | K130840 | 000 |
| 08800000925226 | K130840 | 000 |
| 08800000925127 | K130840 | 000 |