CALIBRA CEMENT

{0}------------------------------------------------ ## 510(k) SUMMARY K040906 NAME & ADDRESS: DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York. PA 17404 Telefax (717) 849-4343 ## JUN 1 6 2004 | CONTACT: | P. Jeffery Lehn | |----------|-----------------| |----------|-----------------| April 2, 2004 DATE PREPARED: TRADE OR PROPRIETARY NAME: CALIBRA™ CEMENT Dental cement (872.3275) CLASSIFICATION NAME: K940459 PREDICATE DEVICES: Enforce™ with Fluoride Cement CALIBRA™ CEMENT is a visible light cured (VLC), dual-cured, DEVICE DESCRIPTION: or self-cured high strength cement that, with compatible dentin/enamel adhesive systems, adhesively bond and lute indirect restorations to tooth structure. CALIBRA™ CEMENT consists of VLC base paste and catalyst paste. The base paste is mixed with the catalyst paste to form a dual-cured cement. This mixed version of the cement will self-cure or can be light-cured, or both. CALIBRA™ CEMENT also includes a set of try-in pastes. These try-in pastes are highly water-soluble and easily rinsed away, and are used to mimic the shade of the cured cement prior to final cementation in order to ensure a good match to the adjacent dentition. CALIBRA™ CEMENT is indicated for the adhesive cementation of: INTENDED USE: 1) ceramic, porcelain, or composite inlays/onlays, veneers, or crowns; 2) all metal crowns, bridges, inlays/onlays including precious, semi-precious, and non-precious metals; 3) PFM (porcelain fused to metal) crowns and bridges; 4) prefabricated and cast posts; and 5) resin-bonded retainer bridges (Maryland bridges). TECHNOLOGICAL CHARACTERISTICS: All of the components found in CALIBRA™ CEMENT have been used in legally marketed devices. Because of the nearly equivalent material composition of CALIBRA™ CEMENT to the predicate device, no additional toxicity testing was necessary. We believe that the prior use of the components of CALIBRA™ CEMENT in legally marketed devices and the performance data provided support the safety and effectiveness of CALIBRA™ CEMENT for the intended uses. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUN 1 6 2004 Mr. P. Jeffery Lehn Ivi. I : Jeffery Loin. Director of Corporate Compliance and Regulatory Affairs Dentsply International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17404 Re: K040906 Trade/Device Name: CALIBRA™ CEMENT Regulation Number: 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: April 5, 2004 Received: April 7, 2004 Dear Mr. Lehn: ・・ We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section over 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 Interstate commerce prior to that have been reclassified in accordance with the provisions of Ameliuments, or to arrive Act (Act) that do not require approval of a premarket the rederal I ood, Drag, are Coou may, therefore, market the device, subject to the general approvin appression (the Act. The general controls provisions of the Act include connects 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 If your device is classinod (boo as additional controls. Existing major regulations affecting (1 MA), it may be subject to tack of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {2}------------------------------------------------ Page 2 - Mr. Lehn Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA s issualled of a basedan the states with other requirements mean that FDA has made a deceminations administered by other Federal agencies. of the Act of any I cochar statutes and regarments, including, but not limited to: registration Y ou must colliply with an the Fee broquies and (1); good manufacturing practice and listing (21 CFR Part 607), laboling (21 CFR Part 820) regulation (21 CFR Part 820); and if requirements as set form in the quality of sections (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) This letter will anow you to begin mainer of substantial equivalence of your device to a premiarket notification. The PDF Imaling or 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), If you desire specific advice to: Jour de at (301) 594-4613. Also, please note the regulation prease contact the Office or Ochipments premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Inay obtain other general meetirs, International and Consumer Assistance at its toll-free DIVIsion 01.Binan 2041 or (301) 443-6597 or at its Internet address Sincerely yours, Kein Muluy 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) K040906 510(K) Number (if known): Device Name: CALIBRA™ CEMENT Indications for Use: Adhesive cementation of: - 1) ceramic, porcelain, or composite inlays/onlays, veneers, or crowns; - 1) Ccraine, porcenain, or componys including precious, semi-precious, and non-precious metals; - 3) PFM (porcelain fused to metal) crowns and bridges; - 4) prefabricated and cast posts; and - 5) resin-bonded retainer bridges (Maryland bridges) Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) Conc AND/OR Over-The-Counter Use (Part 21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | urrence of CDRH, Office of Device Evaluation (ODE) | |----------------------------------------------------| |----------------------------------------------------| Suann Rurke (Division Sign-Off) Division of Anesthesiology, General Hospital Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 510(k) Number: K Premarket Notification