MODIFICATION OF PQ1

K983668 · Ultradent Products, Inc. · KLE · Nov 30, 1998 · Dental

Device Facts

• Record ID: K983668
• Device Name: MODIFICATION OF PQ1
• Applicant: Ultradent Products, Inc.
• Product Code: KLE · Dental
• Decision Date: Nov 30, 1998
• 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. Ease of use and unsurpassed bond strength in a single syringe primer/ocnding resin makes PQ1 the agent of choice for most light cure bonding needs. Also use PQ1 with chemical sure luting and chemical cure composite (e.g. Permalute). PQ1 is conducive for bonding to: 1. Dentin and Enamel i sing composite or amalgam 2. Porcelain 3. Metal 4. Composite repair

Device Story

PQ1 is a single-syringe primer/bonding resin used in restorative dentistry. It functions as an adhesive agent for bonding restorative materials—composite or amalgam—to tooth structures (dentin/enamel) and other substrates including porcelain and metal. It is compatible with both light-cure and chemical-cure luting agents and composites. The device is intended for professional use by dentists in a clinical setting. By providing a high-strength bond, it facilitates the secure attachment of restorative materials, aiding in the repair and reconstruction of teeth.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Single-syringe primer/bonding resin system. Designed for light-cure and chemical-cure compatibility. No specific materials, dimensions, or software components described.

Indications for Use

Indicated for restorative dentistry bonding procedures, including bonding to dentin, enamel, porcelain, metal, and composite repair, using light-cure or chemical-cure composites and luting agents.

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.

Reference Devices

• Permalute

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 3 0 1998

Mr. Scott E. Moore Vice President Operations Ultradent Products, Incorporated 505 West 10200 South South Jordan, Utah 84095

K983668 Re : Modification of PQ1 Trade Name: Requlatory Class: II Product Code: KLE Dated: October 14, 1998 Received: October 19, 1998

Dear Mr. Moore:

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 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). You may, therefore, market the device, subject to the general The general controls controls provisions of the Act. 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 (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. ਬ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. Moore

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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 requlation (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" (21CFR 807.97). Other qeneral 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.gov/cdrh/dsma/dsmamajn.html".

Sincerely yours,

Timothy A. Ulatowski

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

Enclosure

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| 510(k) Number (if known): | Unknown |
|---------------------------|---------|
| Device Name: | PO1 |

Indications For Use:

Use for almost all bonding needs in restorative dentistry. Ease of use and unsurpassed bond strength in a single syringe primer/ocnding resin makes PQ1 the agent of choice for most light cure bonding needs. Also use PQ1 with chemical sure luting and chemical cure composite (e.g. Permalute). PQ1 is conducive for bonding to:

- 1. Dentin and Enamel i sing 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
Sandra L Shire for MSR

Over-The-Counter Use

(Optional Format 1-2-9

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number_K 983668

Hospital Devices
Number K483669