The following data is part of a premarket notification filed by Dsm Biomedical with the FDA for Dsm Biomedical Dental Bone Graft Plus.
| Device ID | K193212 |
| 510k Number | K193212 |
| Device Name: | DSM Biomedical Dental Bone Graft Plus |
| Classification | Bone Grafting Material, Animal Source |
| Applicant | DSM Biomedical 735 Pennsylvania Drive Exton, PA 19431 |
| Contact | Susan Pileggi |
| Correspondent | Susan Pileggi DSM Biomedical 735 Pennsylvania Drive Exton, PA 19431 |
| Product Code | NPM |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-21 |
| Decision Date | 2020-09-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812337020275 | K193212 | 000 |
| 00812337020244 | K193212 | 000 |