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PQ1 Tooth Bonding Resin Agent

by Ultradent Products, Inc. 2 variants

510(k) K023042

Active European Union and United States

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K023042↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Traditional NumberK023042 Date28 Oct 2002ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

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

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

Full name
PQ1
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, 18 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 PQ1 is a resin-based agent for tooth bonding, classified as a dental adhesive under the OpenFDA nomenclature. It is designed to bond dental restorative materials to tooth structure, ensuring durable and strong adhesion for restorative procedures such as fillings, crowns, or other dental repairs.

This agent is supplied as a single-use product and is intended for use in dental clinical settings. It is not sterile at the point of sale but is packaged in a manner that maintains sterility until first use. The device is classified as Class II under FDA regulations and is authorized through a 510(k) clearance and MDR compliance. Multiple registration numbers and FEI numbers are associated with its distribution, reflecting its regulatory approvals and tracking.

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Questions

AI-generated answers, 18 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 PQ1 used for in dental procedures, and how does it differ from other bonding agents?

    The PQ1 is a resin-based dental adhesive designed specifically to bond restorative materials—such as fillings, crowns, or other repairs—to tooth structure. Unlike some alternatives, it is formulated to create a durable and strong adhesion, ensuring long-lasting results for restorative work. This makes it particularly useful for procedures requiring reliable bonding, such as composite restorations or indirect restorations.

  • Is the PQ1 sterile when it arrives at the dental clinic, and how should it be handled to maintain sterility?

    The PQ1 is not sterile at the point of sale, but it is packaged in a way that preserves sterility until its first use. Clinicians should follow standard aseptic techniques when opening the packaging to avoid contamination. Since it is a single-use product, it should only be used once and then discarded.

  • How is the PQ1 supplied, and are there different sizes or models available?

    The PQ1 is supplied as a single-use product for clinical dental settings. While the data does not specify multiple sizes or models, its classification as a resin-based tooth bonding agent suggests it is likely available in standard application formats (e.g., syringes or bottles) suitable for typical restorative procedures. For exact variations, refer to the manufacturer’s packaging or technical documentation.

  • What regulatory pathway does the PQ1 follow, and how does this affect its use in clinical practice?

    The PQ1 is authorized through FDA 510(k) clearance and MDR compliance, classifying it as a Class II device under FDA regulations. This means it has undergone premarket review to demonstrate substantial equivalence to a predicate device, ensuring its safety and effectiveness for bonding dental restorations. Clinicians can rely on this regulatory pathway as evidence of its validated performance, though local dental practice guidelines should still be followed.

  • Are there any specific storage requirements for the PQ1 before use?

    While the data does not detail exact storage conditions, resin-based dental adhesives like the PQ1 typically require protection from extreme temperatures, moisture, and direct light. The manufacturer’s packaging is designed to maintain sterility until first use, so clinicians should store it in a clean, dry environment as recommended by the manufacturer to preserve its integrity.