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K Number
K983547
Device Name
PROTECH PLUS
Manufacturer
PROTECH, INC.
Date Cleared
1999-01-07

(90 days)

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

ProTech's Denture Relining, Repairing/Rebasing Resin is indicated for relining a denture surface that contacts tissue, to repair a fracture denture, or to form a new denture base.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a dental product. It does not contain information about acceptance criteria or a study proving device performance as typically expected for imaging or AI-based medical devices. The letter is a regulatory document confirming that the device, ProTech Plus Denture Relining, Repairing/Rebasing Resin, is substantially equivalent to legally marketed predicate devices for its stated indications for use.

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.