← Product Code [KLE](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE) · K023042

# PQ1 (K023042)

_Ultradent Products, Inc. · KLE · Oct 28, 2002 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE/K023042

## Device Facts

- **Applicant:** Ultradent Products, Inc.
- **Product Code:** [KLE](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE.md)
- **Decision Date:** Oct 28, 2002
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.3200
- **Device Class:** Class 2
- **Review Panel:** Dental
- **Attributes:** Therapeutic

## Intended Use

Use for almost all bonding needs in restorative dentistry. Chemical cure luting and chemical cure composites, namely PermaFlo DC, also bonds to light cured PQ1. PQ1 is conducive for bonding to: 1. Dentin and Enamel using composite or amalgam 2. Porcelain 3. Metal 4. Composite repair

## Device Story

PQ1 Single Syringe Bonding Agent is a dental adhesive used by dentists in clinical settings. It functions as a resin bonding agent to facilitate adhesion between tooth structures (dentin/enamel) and restorative materials (composite, amalgam, porcelain, metal). The device is applied by the clinician to the prepared tooth surface or restoration site to improve bond strength. It is compatible with both light-cured and chemical-cure restorative systems, including PermaFlo DC. By providing a reliable interface between the tooth and the restorative material, it aids in the retention and sealing of dental restorations, potentially reducing microleakage and improving clinical outcomes for patients requiring restorative dental procedures.

## Clinical Evidence

No clinical data provided; bench testing only.

## Technological Characteristics

Resin-based tooth bonding agent. Classified as a Class II medical device under 21 CFR 872.3200 (Product Code: KLE). Formulated for chemical and light-cure compatibility.

## Regulatory 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.

## Reference Devices

- PermaFlo DC

## Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The logo is black and white and appears to be from a scanned document.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Markus Gee Regulatory Affairs Manager Ultradent Products. Incorporated 505 West 10200 South . . South Jordan, Utah 84095

Re: K023042

Trade/Device Name: PQ1® Single Syringe Bonding Agent Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: September 09, 2002 Received: September 12, 2002

Dear Mr. Gee:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

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## Page 2 - Mr. Markus Gee

You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ukstowski

Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| 510(k) Number (if known): | KO23042 |
|---------------------------|---------|
|---------------------------|---------|

PO1 Single Syringe Bonding Agent Device Name:

### Indications For Use:

Use for almost all bonding needs in restorative dentistry. Chemical cure luting and chemical cure composites, namely PermaFlo DC, also bonds to light cured PQ1. PQ1 is conducive for bonding to:

- 1. Dentin and Enamel using composite or amalgam
- 2. Porcelain
- 3. Metal
- 4. Composite repair

## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

# Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ (Per 21 CFR 801.109 OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

**(Optional Format 1-2-96**

Suam Kury

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number:

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE/K023042](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE/K023042)

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