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K Number
K033020
Device Name
IMPAK ACRYLIC REPAIR RESIN LIQUID
Manufacturer
CMP INDUSTRIES LLC.
Date Cleared
2003-12-19

(84 days)

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

CMP' IMPAK denture relining, repairing/rebasing liquid resin is indicated for relining a denture surface which contains tissue, for repairing a fractured denture, or forming 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 device. It does not contain information about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, or ground truth establishment. This type of information is typically found in the 510(k) summary or in the actual premarket notification submission, but not in the clearance letter itself.

§ 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.