QUIXX POSTERIOR RESTORATIVE

K040144 · Dentsply International · EBF · Apr 1, 2004 · Dental

Device Facts

• Record ID: K040144
• Device Name: QUIXX POSTERIOR RESTORATIVE
• Applicant: Dentsply International
• Product Code: EBF · Dental
• Decision Date: Apr 1, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

QUIXX™ POSTERIOR RESTORATIVE is indicated for posterior Class I and II cavities.

Device Story

QUIXX™ Posterior Restorative is a hybrid resin-composite material used for filling posterior dental cavities. The device is supplied as a single paste; it is applied by a dental professional and cured using visible light. The restorative material is designed to fill Class I and II cavities. It functions as a direct restorative material to replace lost tooth structure, aiding in the restoration of tooth function and aesthetics.

Clinical Evidence

Bench testing only. Biocompatibility testing for cytotoxicity and mutagenicity was performed, with results indicating the material is non-cytotoxic and non-mutagenic.

Technological Characteristics

Hybrid resin-composite restorative material; single paste formulation; visible light-cured. Components are identical to those used in legally marketed predicate devices.

Indications for Use

Indicated for posterior Class I and II cavities.

Regulatory Classification

Identification

Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.

Predicate Devices

• Dyract® AP Restorative (K973235)
• SureFilTM Posterior Restorative (K973221)

Submission Summary (Full Text)

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DENTSPLY

## NAME & ADDRESS:

## DENTSPLY International

World Headquarters Susquehanna Commerce Center 221 West Philadelphia Street York, PA 17405-0872 717) 845-7511 (voice) 17) 849-4762 (tax) www.dentsplv.com

Corporate Compliance Telefax [phone]

P. Jeffery Lehn CONTACT:

January 21, 2004 DATE PREPARED:

QUIXX™ POSTERIOR RESTORATIVE TRADE OR PROPRIETARY NAME:

CLASSIFICATION NAME: Tooth shade resin material (872.3690

K973235 Dyract® AP Restorative PREDICATE DEVICES: SureFilTM Posterior Restorative K973221

DEVICE DESCRIPTION: QUIXX™ POSTERIOR RESTORATIVE is a hybrid resincomposite restorative material for use in filling posterior dental cavities. The restorative consists of a single paste that is visible light cured.

INTENDED USE: QUIXX™ POSTERIOR RESTORATIVE is indicated for posterior Class I and II cavities.

TECHNOLOGICAL CHARACTERISTICS: All of the components of QUIXX™ POSTERIOR RESTORATIVE are found in the legally marketed predicate devices. K973221 and K973235.

OUIXX™ POSTERIOR RESTORATIVE was tested for cytotoxicity and mutagenicity and found to be non-cytotoxic and non-mutagenic.

The prior use of all of the components in legally marketed predicate devices support our decision that additional biocompatibility studies with the final formulation are not necessary.

We believe that the prior use of the components of QUIXX™ POSTERIOR RESTORATIVE in legally marketed devices, and the performance data and results of biocompatibility testing provided, support the safety and effectiveness of QUIXX™ POSTERIOR RESTORATIVE for the intended use.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR = 1 2004

Dentsply International Mr. P. Jeffery Lehn Director of Corporate Compliance & Regulatory Affairs World Headquarters Susquehanna Commerce Center 221 West Philadelphia Street York, Pennsylvania 17405-0872

Re: K040144

Trade/Device Name: QUIXX™ Posterior Restorative Regulation Number: 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: January 21, 2004 Received: January 22, 2004

Dear Mr. Lehn:

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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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. 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,

Clerk

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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## INDICATIONS FOR USE STATEMENT

(As Required by 21 CFR 807.87(e)

10 40144 510(K) Number (if known):

Device Name:

QUIXX™ POSTERIOR RESTORATIVE

Indications for Use:

Indicated for posterior Class I and II cavities.

Susan Runns

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

K64014L 510(k) Number:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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