The following data is part of a premarket notification filed by Geistlich-pharma with the FDA for Bio-oss Ceramic.
| Device ID | K952619 |
| 510k Number | K952619 |
| Device Name: | BIO-OSS CERAMIC |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | GEISTLICH-PHARMA ARENT, FOX, KINTNER, PLOTKIN & 1050 CONNECTICUT AVENUE Washington, DC 20003 -6 |
| Contact | Peter S Reichertz |
| Correspondent | Peter S Reichertz GEISTLICH-PHARMA ARENT, FOX, KINTNER, PLOTKIN & 1050 CONNECTICUT AVENUE Washington, DC 20003 -6 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-06 |
| Decision Date | 1995-08-28 |