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K Number
K981861
Device Name
LINER 1:HARD RELINE LIQUID
Manufacturer
HARRY J. BOSWORTH CO.
Date Cleared
1998-10-01

(141 days)

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

Hard Reline Liquid is used as a hard liner and repair material for removable dentures.

Device Description

LINER I: HARD RELINE LIQUID

AI/ML Overview

I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a dental product called "Liner 1: Hard Reline Liquid." It confirms the device's substantial equivalence to a legally marketed predicate device.

The letter does not contain any information about acceptance criteria, a study proving device performance, sample sizes, data provenance, expert qualifications, ground truth establishment, or any details related to AI performance or comparative effectiveness studies. Therefore, I cannot fulfill your request to describe these aspects based on the given input.

§ 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.