(70 days)
QUIXX™ POSTERIOR RESTORATIVE is indicated for posterior Class I and II cavities.
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.
This document is a 510(k) premarket notification for a dental restorative material, not a study evaluating an AI-powered medical device. Therefore, it does not contain the information required to answer the questions about acceptance criteria, study design, expert involvement, and AI performance.
The document describes a conventional dental product, "QUIXX™ POSTERIOR RESTORATIVE," and its technological characteristics and intended use, comparing it to predicate devices. It discusses biocompatibility testing (cytotoxicity and mutagenicity) but does not involve any AI components or a study comparing its performance against specific acceptance criteria in the manner requested.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, expert qualifications, or AI-related study findings from the provided text.
{0}------------------------------------------------
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 (717) 849-4343
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.
{1}------------------------------------------------
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.
{2}------------------------------------------------
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 (301) 594-5613. 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 (800) 638-2041 or (301) 443-6597 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
{3}------------------------------------------------
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)
. .
7
§ 872.3690 Tooth shade resin material.
(a)
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.(b)
Classification. Class II.