The following data is part of a premarket notification filed by Steiner Laboratories with the FDA for Socket Graft.
| Device ID | K113049 |
| 510k Number | K113049 |
| Device Name: | SOCKET GRAFT |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | STEINER LABORATORIES 590 FARRINGTON HWY. #524 SUITE 132 Kapolei, HI 96707 |
| Contact | Gregory G Steiner |
| Correspondent | Gregory G Steiner STEINER LABORATORIES 590 FARRINGTON HWY. #524 SUITE 132 Kapolei, HI 96707 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-13 |
| Decision Date | 2012-01-27 |
| Summary: | summary |