# K113282: Cerasorb Dental,Ceradorb M Dental, Cerasorb Perio

- Pathway: 510(k) (Special)
- Applicant: Riemser Arzeimittel AG
- Decided: Sep 20, 2012 after 318 days
- Product code: LYC (Bone Grafting Material, Synthetic)
- Device class: 2
- Regulation: 21 CFR 872.3930
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K941780 (1995). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051443: Cerasorb Dental, Cerasorb M Dental and Cerasorb Perio, Curasan Ag, Frankfurt Facility (2005) Summary page 3.

## Indications for use
Cerasorb® CLASSIC is recommended for: - Augmentation or reconstructive treatment of the alveolar ridge. - Filling of infrabony periodontal defects. - Filling of defects after root resection, apicoectomy, and cystectomy. - Filling of extraction sockets to enhance preservation of the alveolar ridge. - Elevation of the maxillary sinus floor. - Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR). - Filling of perio-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR). Cerasorb® M is recommended for: - Augmentation or reconstructive treatment of the alveolar ridge. - Filling of infrabony periodontal defects. - Filling of defects after root resection, apicoectomy, and cystectomy. - Filling of extraction sockets to enhance preservation of the alveolar ridge. - Elevation of the maxillary sinus floor. - Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR). - Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR). Cerasorbe Perio is recommended for: - Filling and/or reconstruction of non-infected periodontal bone defects in conjunction with other products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR). - Filling of infrabony periodontal defects - Filling of single-or multi-wall bone pockets- - Filling of bifurcations and trifurcations

Source page: https://510kreport.com/device/K113282
Methodology: https://510kreport.com/methodology