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510(k) Data Aggregation
K Number
K051091Device Name
SYNTHOGRAFTManufacturer
Date Cleared
2005-09-01
(126 days)
Product Code
Regulation Number
872.3930Type
TraditionalPanel
DentalReference & Predicate Devices
N/A
Why did this record match?
Device Name :
SYNTHOGRAFT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Synthograft is designed for:
- the filling and or reconstruction of either traumatic or degenerative multi-wall bone defects
- the augmentation of the sinus floor
- the augmentation of the alveolar ridges
- the augmentation of the alveblar hagos
- the filling of periodontal or other alveolar bone defects and tooth sockets and osteotomies
- the preservation of the alveolus for the preparation of an implant site.
Device Description
Not Found
AI/ML Overview
This document is a 510(k) substantial equivalence letter for a device named "Synthograft," a bone grafting material. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria, as it is a regulatory clearance document rather than a performance study report.
Therefore, I cannot provide a response filling in the requested information as the source text does not contain such details. The document primarily focuses on the FDA's determination of substantial equivalence to a predicate device and outlines regulatory conditions for marketing.
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