The following data is part of a premarket notification filed by Curasan Ag with the FDA for Curasan Osseolive Dental.
| Device ID | K111105 |
| 510k Number | K111105 |
| Device Name: | CURASAN OSSEOLIVE DENTAL |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | CURASAN AG PIAZZA ALBANIA 10 Rome, IT 00153 |
| Contact | Roger Gray |
| Correspondent | Roger Gray CURASAN AG PIAZZA ALBANIA 10 Rome, IT 00153 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-20 |
| Decision Date | 2012-12-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| ECURL20V1000 | K111105 | 000 |
| ECURL05M1000 | K111105 | 000 |
| ECURL05V0250 | K111105 | 000 |
| ECURL05V1000 | K111105 | 000 |
| ECURL10M0250 | K111105 | 000 |
| ECURL10M1000 | K111105 | 000 |
| ECURL10V0250 | K111105 | 000 |
| ECURL10V1000 | K111105 | 000 |
| ECURL20M0250 | K111105 | 000 |
| ECURL20M1000 | K111105 | 000 |
| ECURL20V0250 | K111105 | 000 |
| ECURL05M0250 | K111105 | 000 |