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K Number
K150454
Device Name
Acryfree Denture Base Material and Biosens Denture Base Material
Manufacturer
PERFLEX
Date Cleared
2015-05-26

(95 days)

Product Code
EBI,MQC
Regulation Number
872.3760
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
K213994
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

"Acryfree Denture Base Material" and "Biosens Denture Base Material" are intended for manufacturing, relining, repairing, and rebasing of partial or full removable dentures, dental plates, personal trays, appliances, occlusal splints and night guards.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification decision letter from the FDA for denture base materials. It does not contain information about the acceptance criteria or a study proving that the device meets acceptance criteria. The document confirms that the devices are substantially equivalent to legally marketed predicate devices and outlines regulatory compliance requirements. It also includes the "Indications for Use" for the devices.

Therefore, I cannot provide the requested information based on the provided text.

§ 872.3760 Denture relining, repairing, or rebasing resin.

(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.