The following data is part of a premarket notification filed by Steiner Laboratories with the FDA for Socket Graft.
| Device ID | K052493 |
| 510k Number | K052493 |
| Device Name: | SOCKET GRAFT |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | STEINER LABORATORIES 590 FARRINGTON HWY. #524 SUITE 132 Kapolei, HI 96707 |
| Contact | Gregory Gene Steiner |
| Correspondent | Gregory Gene 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 | 2005-09-12 |
| Decision Date | 2006-06-09 |