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510(k) Data Aggregation
K Number
K101426Device Name
CEROS TCP GRANULES
Manufacturer
MATHYS LTD
Date Cleared
2010-09-15
(117 days)
Product Code
LYC
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
MATHYS LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Ceros® TCP Granules are indicated for use as a bone void filler in non-loadbearing areas in the oral and maxillofacial regions requiring cancellous rather than cortical bone material. Ceros TCP Granules may, for example, be used for:
- · supplementing autogenous cancellous bone
- · supporting and stabilizing for guided bone regeneration, "GBR"
- · filling bone cavities after hemisection of teeth, bone removal, osteotomy, tumor resection, root apex resection, tooth extraction or cystectomy
- · filling bone defects resulting from traumatic or pathological origin
- · augmenting an atrophied mandibular ridge (only in conjunction with the "GBR" membrane technique)
- · filling defects after explantation of dental implants
- · filling small periodontal bone cavities as well as bi- and tri-furcations of teeth
- · the reconstruction of alveolar defects prior to providing a prosthesis
- · preparation of the implant bed (e.g. sinus lift)
- · filling bone defects around dental implant after immediate placement into extraction sockets
Ceros® TCP Granules are intended to be gently packed or placed into the surgical site and may be combined with autogenous blood, bone marrow or saline.
Device Description
Ceros® TCP Granules are a synthetic, porous, osteoconductive, bioresorbable bone grafting material composed of beta-tricalcium phosphate, ß-TCP, [ß-C23]PO4]2] intended to fill, augment, or reconstruct bony defects in dental, oral or maxillofacial surgery. Ceros® TCP Granules are provided in volumes of 0.5, 1.0 and 2.5 g.
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