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Proclude-Sensitive

by Ortek Therapeutics, Inc.

510(k) K003482

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK003482 Date1 Feb 2001ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LBH
Device Class
Class II
Regulation
21 CFR Part 872.3260
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

PROCLUDE-SENSITIVE is a dental cavity varnish used in restorative dentistry to seal prepared tooth surfaces and protect against microleakage and postoperative sensitivity. It is applied as a thin, protective coating over etched enamel and dentin margins following cavity preparation.

The device is supplied as a single-use varnish formulation intended for professional application in dental settings. It is regulated under FDA product code LBH as a Class II device with a Traditional 510(k) clearance pathway. Storage conditions and specific handling instructions are not detailed in the available data.

Other devices from Ortek Therapeutics, Inc.

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is PROCLUDE-SENSITIVE used for?

    It is used in restorative dentistry to seal prepared tooth surfaces. The varnish acts as a protective coating over etched enamel and dentin margins after cavity preparation, helping to prevent microleakage and reduce postoperative sensitivity.

  • How is PROCLUDE-SENSITIVE supplied?

    It is supplied as a single-use varnish formulation. The device is intended for professional application only and is designed to be used in dental clinical settings by trained practitioners.

  • Is PROCLUDE-SENSITIVE sterile?

    The available device data does not specify whether PROCLUDE-SENSITIVE is supplied sterile. Users should consult the manufacturer’s labeling or contact Ortek Therapeutics, Inc. for details on sterility claims prior to clinical use.

  • Can PROCLUDE-SENSITIVE be reused?

    No, PROCLUDE-SENSITIVE is explicitly described as a single-use formulation. Reuse is not indicated, and the device is designed for one-time professional application to ensure consistency and patient safety.

  • What is the regulatory classification of PROCLUDE-SENSITIVE?

    PROCLUDE-SENSITIVE is regulated under FDA product code LBH as a Class II device. It followed the Traditional 510(k) clearance pathway and was reviewed by the Dental advisory committee, with a decision of substantial equivalence recorded.