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K Number
K973285
Device Name
D/SENSE-T
Manufacturer
CENTRIX, INC.
Date Cleared
1998-02-25

(176 days)

Product Code
KLE
Regulation Number
872.3200
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

To Reduce dentin sensitivity PRIOR TO cementing CROWNS, Bridges, etc. Also for Reducing dentin sensitivity in Class V CROSTOWSO

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification from the FDA regarding the "D/Sense-T" device. It does not contain any information about acceptance criteria, device performance, ground truth, study design, or sample sizes.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document only confirms that the FDA has reviewed the submission and found the device substantially equivalent to legally marketed predicate devices for the stated indications for use (to reduce dentin sensitivity prior to cementing crowns, bridges, etc., and for reducing dentin sensitivity in Class V restorations).

§ 872.3200 Resin tooth bonding agent.

(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.