The following data is part of a premarket notification filed by Dentsply International, Inc. with the FDA for Osteograf/ld-300.
| Device ID | K072057 |
| 510k Number | K072057 |
| Device Name: | OSTEOGRAF/LD-300 |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | DENTSPLY INTERNATIONAL, INC. SUSQUEHANNA COMMERCE CTR., 221 W. PHILADELPHIA ST., SUITE 60 York, PA 17404 |
| Contact | Helen Lewis |
| Correspondent | Helen Lewis DENTSPLY INTERNATIONAL, INC. SUSQUEHANNA COMMERCE CTR., 221 W. PHILADELPHIA ST., SUITE 60 York, PA 17404 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-26 |
| Decision Date | 2007-08-06 |
| Summary: | summary |