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510(k) Data Aggregation
K Number
K111809Manufacturer
Date Cleared
2011-09-26
(91 days)
Product Code
Regulation Number
872.3640Type
SpecialPanel
DentalReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The SL Type and SPL Type Orthodontic Anchor Screws are intended for use as a temporary anchor for orthodontic treatment.
Device Description
Not Found
AI/ML Overview
The provided text describes an FDA 510(k) clearance letter for SL Type and SPL Type Orthodontic Screws. It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. The document only confirms that the FDA has reviewed the premarket notification and determined the device to be substantially equivalent to legally marketed predicate devices for its stated indications for use.
Therefore, I cannot provide the requested information.
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