PQ 1

K974283 · Ultradent Products, Inc. · KLE · Jan 29, 1998 · Dental

Device Facts

• Record ID: K974283
• Device Name: PQ 1
• Applicant: Ultradent Products, Inc.
• Product Code: KLE · Dental
• Decision Date: Jan 29, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

PQ 1 PermaQuick Bonding System is used for 95% of bonding needs in restorative dentistry . Ease of use I Q 1 t offinaQuick Donaling Cycleral as PQ 1 the agent of choice for all light cure bonding needs. PQ 1 is conducive for bonding to: 1. Dentin and Enamel using composite or amalgam. 2. Porcelain 3. Metal 4. Composite repair

Device Story

PQ 1 PermaQuick Bonding System is a dental adhesive material used by dentists in clinical settings. It functions as a bonding agent for restorative procedures, specifically for adhering composite or amalgam to dentin and enamel, as well as bonding to porcelain, metal, and existing composite surfaces. The material is applied by the clinician to the prepared tooth or restorative surface and cured using a light-curing device. By creating a bond between the tooth structure and restorative materials, it facilitates the repair and restoration of teeth, potentially improving the longevity and structural integrity of dental restorations.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Light-cured dental bonding agent. Formulated for adhesion to dentin, enamel, porcelain, metal, and composite substrates. Applied via manual clinical technique.

Indications for Use

Indicated for use in restorative dentistry for bonding dentin, enamel, porcelain, metal, and composite repairs using light-cure bonding techniques. Prescription use only.

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

2 9 1998

Mr. Chester McCoy Requlatory Affairs Manager Ultradent Products, Incorporated 505 W. 10200 South 84065 South Jordan, Utah

K974283 Re : Trade Name: PQ 1 Requlatory Class: II Product Code: KLE Dated: November 10, 1997 November 14, 1997 Received:

Dear Mr. McCoy:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, listing of devices, good manufacturing practice, labelinq, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does

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Page 2 - Mr. McCoy

not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".

Sincerely yours

Timothy A. Ulatowski

Directpr Divisibn of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| 17, | 18<br>C<br>C | |
|-----|--------------|--|
|-----|--------------|--|

510(k) Number (if known):

Device Name: _PQ 1

Indications For Use:

PQ 1 PermaQuick Bonding System is used for 95% of bonding needs in restorative dentistry . Ease of use I Q 1 t offinaQuick Donaling Cycleral as PQ 1 the agent of choice for all light cure bonding needs. PQ 1 is conducive for bonding to:

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

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

Susa Risser
Division Sign. Off.

(Division Sign-Off) Division of Dental. Infection Control, and General Hospital Devices 510(k) Number .

**Prescription Use**
(Per 21 CFR §01.109) Yes

OR

Over-The-Counter Use الم

(Optional Format 1-2-96)