The following data is part of a premarket notification filed by Kensey Nash Corporation Dba Dsm Biomedical with the FDA for Dsm Biomedical Dental Bone Graft.
| Device ID | K170245 |
| 510k Number | K170245 |
| Device Name: | DSM Biomedical Dental Bone Graft |
| Classification | Bone Grafting Material, Animal Source |
| Applicant | Kensey Nash Corporation Dba DSM Biomedical 735 Pennsylvania Drive Exton, PA 19341 |
| Contact | Susan Pileggi |
| Correspondent | Susan Pileggi Kensey Nash Corporation Dba DSM Biomedical 735 Pennsylvania Drive Exton, PA 19341 |
| Product Code | NPM |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-26 |
| Decision Date | 2017-05-16 |
| Summary: | summary |