The following data is part of a premarket notification filed by Curasan Ag, Frankfurt Facility with the FDA for Cerasorb Dental, Cerasorb M Dental And Cerasorb Perio.
| Device ID | K051443 |
| 510k Number | K051443 |
| Device Name: | CERASORB DENTAL, CERASORB M DENTAL AND CERASORB PERIO |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | CURASAN AG, FRANKFURT FACILITY 109 SHORE DRIVE Garner, NC 27529 |
| Contact | Eric Wiechert |
| Correspondent | Eric Wiechert CURASAN AG, FRANKFURT FACILITY 109 SHORE DRIVE Garner, NC 27529 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-02 |
| Decision Date | 2005-07-22 |
| Summary: | summary |