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K Number
K041680
Device Name
ORAJEL ADVANCED TOOTH DESENSITIZER
Manufacturer
DEL PHARMACEUTICALS, INC.
Date Cleared
2004-11-10

(142 days)

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

Tooth Desensitizer Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D) . AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

Device Description

Not Found

AI/ML Overview

This is a 510(k) premarket notification for the Orajel Advanced Tooth Desensitizer, a resin tooth bonding agent. This document does not describe the acceptance criteria or a study proving the device meets acceptance criteria. It is a regulatory approval document from the FDA stating that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information from the provided text.

§ 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.