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510(k) Data Aggregation
K Number
K051443Device Name
CERASORB DENTAL, CERASORB M DENTAL AND CERASORB PERIO
Manufacturer
CURASAN AG, FRANKFURT FACILITY
Date Cleared
2005-07-22
(50 days)
Product Code
LYC
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
CURASAN AG, FRANKFURT FACILITY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Cerasorb® M DENTAL 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).
Cerasorb® DENTAL 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).
Cerasorb® 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
Device Description
Cerasorb® DENTAL, Cerasorb® M DENTAL and Cerasorb® Perio are a sterile, synthetic, ceramic matrix in either granular form (Cerasorb DENTAL), polygonal shaped morsels (Cerasorb M DENTAL) or polygonal broken granulate (Cerasorb Perio). This material consists of pure-phase Beta-Tricalcium Phosphate with a phase purity of > 97% and complies with the ASTM F 1088-04. The devices, when applied to a bony defect, create a matrix of large, smoothly interconnected pores providing an osteoconductive scaffold (Cerasorb DENTAL approx. 65 vol% [total porosity], Cerasorb M DENTAL approx. 65 vol% [total porosity] and Cerasorb Perio approx. 25 vol%). The different designs are managed and controlled by a validated manufacturing process which guarantees batch to batch conformity and reproducibility. Due to their synthetic nature the devices are free of any biological contaminants and are neither locally nor systemically toxic. In contact with vital bone the Cerasorb granules, morsels or granulate is resorbed and gradually replaced by new bone. Cerasorb DENTAL, Cerasorb M DENTAL and Cerasorb Perio are provided in double sterile packaging (sterilized by gamma irradiation) and are for single-use only.
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