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Permaquik Bonding Primer

by Ultradent Products, Inc. 2 variants

510(k) K951583

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 NumberK951583 Date12 May 1995ClearedStatusActive

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  • Withdrawn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
KLE
Device class
Class II
Regulation
21 CFR Part 872.3200
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 Sep 2026

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

The PermaQuick Bonding Primer is a dental agent classified as a tooth bonding resin (product code KLE). It functions as a bonding primer designed to enhance adhesion between dental restorative materials and tooth structure, improving the durability and longevity of dental restorations.

This single-use, non-sterile liquid primer is intended for use in dental settings. Supplied in a liquid form, it is applied to prepared tooth surfaces prior to bonding procedures. The device is regulated under FDA 510(k) clearance (K951583) and falls under the classification of Class II medical devices under regulation number 872.3200. It is supplied in various vial sizes as indicated by the listed FEI numbers.

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Questions

AI-generated answers, 20 Sep 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 the PermaQuick Bonding Primer used for in dental procedures, and how does it improve restorations?

    The PermaQuick Bonding Primer is a dental agent designed to enhance adhesion between tooth surfaces and restorative materials, such as fillings or crowns. By improving this bond, it helps increase the durability and longevity of dental restorations, reducing the risk of premature failure or gaps at the restoration-tooth interface.

  • Is the PermaQuick Bonding Primer sterile, and how is it supplied for use in a dental office?

    The PermaQuick Bonding Primer is non-sterile and is supplied as a liquid in single-use vials. It comes in multiple vial sizes, as indicated by the listed FEI numbers (e.g., 3038718579, 3008882689), allowing flexibility for different clinical needs. Each vial is intended for one-time use only.

  • Can this bonding primer be reused, or is it meant for single applications only?

    The PermaQuick Bonding Primer is explicitly designed for single-use only. Since it is non-sterile and supplied in individual vials, it should not be reused to maintain proper infection control and ensure optimal performance for each patient.

  • What regulatory pathway was followed for FDA clearance of the PermaQuick Bonding Primer?

    The PermaQuick Bonding Primer received FDA clearance through the 510(k) pathway, specifically under the traditional review process. It was determined to be *substantially equivalent* to a predicate device and falls under Class II medical device classification (regulation number 872.3200). The clearance number is K951583, and the device was reviewed by the Dental (DE) Advisory Committee.