The following data is part of a premarket notification filed by Riemser Arzeimittel Ag with the FDA for Cerasorb Dental,ceradorb M Dental, Cerasorb Perio.
| Device ID | K113282 |
| 510k Number | K113282 |
| Device Name: | CERASORB DENTAL,CERADORB M DENTAL, CERASORB PERIO |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | RIEMSER ARZEIMITTEL AG 5105 FAIROAKS RD Durham, NC 27712 |
| Contact | James M Clinton |
| Correspondent | James M Clinton RIEMSER ARZEIMITTEL AG 5105 FAIROAKS RD Durham, NC 27712 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-07 |
| Decision Date | 2012-09-20 |
| Summary: | summary |