The following data is part of a premarket notification filed by Isotis Nv with the FDA for Ossatura Dental.
| Device ID | K031813 |
| 510k Number | K031813 |
| Device Name: | OSSATURA DENTAL |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | ISOTIS NV 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Mary Mcnamara-cullinane |
| Correspondent | Mary Mcnamara-cullinane ISOTIS NV 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-12 |
| Decision Date | 2004-08-20 |
| Summary: | summary |