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510(k) Data Aggregation
K Number
K113282Device Name
CERASORB DENTAL,CERADORB M DENTAL, CERASORB PERIO
Manufacturer
RIEMSER ARZEIMITTEL AG
Date Cleared
2012-09-20
(318 days)
Product Code
LYC
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
RIEMSER ARZEIMITTEL AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CERASORB® CLASSIC and CERASORB® M are 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® 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® CLASSIC, CERASORB® M and CERASORB® Perio are a sterile, synthetic, porous and biocompatible ceramic matrix in either granular form (CERASORB® CLASSIC), polygonal shaped morsels (CERASORB® M) or polygonal broken granulate (CERASORB® Perio). All designs consist of pure-phase Beta-Tricalcium Phosphate with a phase purity of ≥ 99% and comply with the ASTM F 1088-04. The devices, when applied to a bony defect, create a network of large, smoothly interconnected pores providing different porosities (CERASORB® CLASSIC approx, 35%, CERASORB® M approx. 65 vol% [total porosity] and CERASORB® Perio approx. 25vol%).
The different designs are manufactured by a validated manufacturing process which guarantees batch to batch conformity and reproducibility.
In contact with vital bone the CERASORB® granules, morsels or granulate is resorbed and gradually replaced by new bone.
CERASORB® CLASSIC, CERASORB® M and CERASORB® Perio are provided in double sterile packages (sterilization via gamma irradiation) and are for single-use only.
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