PERMAQUICK SE BONDING SYSTEM

K032626 · Ultradent Products, Inc. · KLE · Dec 3, 2003 · Dental

Device Facts

• Record ID: K032626
• Device Name: PERMAQUICK SE BONDING SYSTEM
• Applicant: Ultradent Products, Inc.
• Product Code: KLE · Dental
• Decision Date: Dec 3, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

Intended Use

Use for almost all bonding needs in restorative dentistry. Bonds chemical cure luting and chemical cure composites, namely PermaFlo DC, also bonds to light cured PermaQuick SE. PermaQuick SE does not require 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 Story

PermaQuick SE Bonding System is a dental adhesive used in restorative dentistry. It functions as a self-etching bonding agent, eliminating the need for a separate etching step. The system bonds chemical cure luting agents, chemical cure composites (e.g., PermaFlo DC), and light-cured composites to tooth structures (dentin/enamel), porcelain, metal, and existing composite restorations. Used by dental professionals in clinical settings to facilitate adhesion during restorative procedures. Benefits include simplified clinical workflow due to the self-etching property and versatility across multiple restorative materials.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Resin-based tooth bonding agent. Self-etching chemistry. Class II device under 21 CFR 872.3200. No specific materials, energy sources, or software components described.

Indications for Use

Indicated for restorative dentistry bonding procedures, including dentin, enamel, porcelain, metal, and composite repair. Suitable for use with chemical cure luting, chemical cure composites, and light-cured composites. No specific age or gender restrictions noted.

Regulatory Classification

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.

Submission Summary (Full Text)

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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