The following data is part of a premarket notification filed by Curasan Ag with the FDA for Ceracell Dental.
| Device ID | K103709 |
| 510k Number | K103709 |
| Device Name: | CERACELL DENTAL |
| Classification | Bone Grafting Material, For Dental Bone Repair |
| 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 | LPK |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-20 |
| Decision Date | 2011-03-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 42604764311288 | K103709 | 000 |
| 04260476431012 | K103709 | 000 |
| 04260476431029 | K103709 | 000 |
| 04260476431036 | K103709 | 000 |
| 04260476431104 | K103709 | 000 |
| 04260476431111 | K103709 | 000 |
| 04260476431128 | K103709 | 000 |
| 42604764310052 | K103709 | 000 |
| 42604764310120 | K103709 | 000 |
| 42604764310298 | K103709 | 000 |
| 42604764310366 | K103709 | 000 |
| 42604764311042 | K103709 | 000 |
| 42604764311110 | K103709 | 000 |
| 04260476431005 | K103709 | 000 |