PERMAQUICK SE BONDING SYSTEM

• K Number: K032626
• Device Name: PERMAQUICK SE BONDING SYSTEM
• Manufacturer: ULTRADENT PRODUCTS, INC.
• Date Cleared: 2003-12-03 ( 99 days)
• Product Code: KLE
• Regulation Number: 872.3200
• Type: Traditional
• Panel: Dental
• Reference & Predicate Devices: N/A
• Predicate For: K063558

Intended Use

Us : for almost all bonding needs in restorative dentistry. Bonds chemical cure luting and chemical cure connosites, namely PermaFlo DC, also bonds to light cured PermaQuick SE. PermaQuick SE docs not recuire a separate etching step for quality adhesion. PermaQuick SE is conducive for bonding to:

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

Device Description

Not Found

AI/ML Overview

This is a 510(k) premarket notification letter for the PermaQuick SF Bonding System. The letter states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain acceptance criteria or study results that prove the device meets acceptance criteria.

The provided text is a regulatory clearance letter and an "Indications For Use" statement. It does not include:

1. A table of acceptance criteria or reported device performance.
2. Details about sample sizes, data provenance, number of experts, adjudication methods, or ground truth for any studies.
3. Information about MRMC comparative effectiveness studies or standalone algorithm performance.
4. Information about training set size or how its ground truth was established.

Therefore, I cannot fulfill your request for this information based on the provided input.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing the wings and body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 3 2003

Ultradent Products, Incorporation Mr. Peter Allred R&D Manager 505 West 10200 South South Jordan, Utah 84095

Re: K032626

Trade/Device Name: PermaQuick SF Bonding System Regulation Number: 872.3200 Regulation Name: Resin tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: August 22, 2003 Received: September 9, 2003

Dear Mr. Allred:

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.

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Page 2 - Mr. Allred

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 modi that I Dr mai made statutes and regulations administered by other Federal agencies. 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Bunner

Chiu Lin. Ph.D. 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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Page 1 of

Ko32626

510(k) Number (if known): Unknown

PermaQuick SE Bonding System Device Name: ________

Indications For Use:

Us : for almost all bonding needs in restorative dentistry. Bonds chemical cure luting and chemical cure connosites, namely PermaFlo DC, also bonds to light cured PermaQuick SE. PermaQuick SE docs not recuire a separate etching step for quality adhesion. PermaQuick SE is conducive for bonding to:

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

(P LEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDE

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _____(Per 21 CFR 801.109

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-4

Robert S. Betz DDS / Dr. Susan Kummer

Division of Anesthesiology, General Hospital, Infection Control. Denta

510(k) Number: K032626

Regulation Number and Section

§ 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.