The following data is part of a premarket notification filed by Impladent, Ltd. with the FDA for Osteogen Sbrg.
| Device ID | K033098 |
| 510k Number | K033098 |
| Device Name: | OSTEOGEN SBRG |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | IMPLADENT, LTD. 198-45 FOOTHILL AVE. Holliswood, NY 11423 |
| Contact | Maurice Valen |
| Correspondent | Maurice Valen IMPLADENT, LTD. 198-45 FOOTHILL AVE. Holliswood, NY 11423 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-29 |
| Decision Date | 2004-04-27 |