The following data is part of a premarket notification filed by Osstem Implant Co.,ltd with the FDA for Smartbuilder System.
| Device ID | K120951 |
| 510k Number | K120951 |
| Device Name: | SMARTBUILDER SYSTEM |
| 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 | 2012-03-30 |
| Decision Date | 2012-10-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800000920993 | K120951 | 000 |
| 08800000921068 | K120951 | 000 |
| 08800000921051 | K120951 | 000 |
| 08800000921044 | K120951 | 000 |
| 08800000921037 | K120951 | 000 |
| 08800000921020 | K120951 | 000 |
| 08800000921013 | K120951 | 000 |
| 08800000921006 | K120951 | 000 |
| 08809917096357 | K120951 | 000 |
| 08809917096326 | K120951 | 000 |
| 08809917096296 | K120951 | 000 |
| 08809917096289 | K120951 | 000 |
| 08809917096128 | K120951 | 000 |
| 08809917096111 | K120951 | 000 |
| 08809917096104 | K120951 | 000 |
| 08809917096098 | K120951 | 000 |
| 08809917096081 | K120951 | 000 |
| 08800000921075 | K120951 | 000 |
| 08800000921082 | K120951 | 000 |
| 08800000920986 | K120951 | 000 |
| 08800000920979 | K120951 | 000 |
| 08800000920962 | K120951 | 000 |
| 08800000920955 | K120951 | 000 |
| 08800000920948 | K120951 | 000 |
| 08800000920931 | K120951 | 000 |
| 08800000920924 | K120951 | 000 |
| 08800000920917 | K120951 | 000 |
| 08800000920900 | K120951 | 000 |
| 08800000961286 | K120951 | 000 |
| 08800000921143 | K120951 | 000 |
| 08800000921136 | K120951 | 000 |
| 08800000921129 | K120951 | 000 |
| 08800000921112 | K120951 | 000 |
| 08800000921105 | K120951 | 000 |
| 08800000921099 | K120951 | 000 |
| 08809917096074 | K120951 | 000 |