COSMEDENT CORE PASTE

{0}------------------------------------------------ ## Cosmedent, Inc. 401 N. Michigan Ave., Ste 2500, Chicago, IL 60611 Page 17 of 19 510(k) submi DRE PASTE ## 510(k) SUMMARY As required by the Safe Medical Devices Act of 1990 ## IDENTIFICATION OF THE LEGALLY MARKETED PREDICATE DEVICES Den-Mat Core Paste Bisco Bis-Core Bisco Bisfil Core The three predicate devices are highly filled resin restorative materials designed to serve as core buildup materials to restore the structural portion of a tooth crown. The built-up structure is intended to be restored with a fixed dental prosthesis such as a crown. These products are fabricated from bis-GMA, urethane, or similar room temperature curing diacrylate monomers that are filled with silanated silica and/or glasses typically formulated with metal oxides which are sufficiently radioapparent as to be visible on clinical radiographs. DESCRIPTION OF THE APPLICANT DEVICE - CORE PASTE CORE PASTE is a dual-cure, radiopaque, filled, resin based core buildup material. The product will self-cure upon mixing equal parts of base and catalyst pastes. The setting time and resultant properties can be improved by further curing with a visible light dental curing unit. CORE PASTE is a high strength product ideally suited to buildup or replace lost tooth structure and to perform as a foundation restoration or core. It is used to build a damaged tooth to ideal anatomic form before it is prepared for a fixed dental prosthesis such as a crown. CORE PASTE is available in three shades: a blue material which serves to sharply contrast with tooth structure, a white opaque shade with similar clinical effects, and an esthetic A2 shade for optimal optical effects under esthetic translucent crown materials. INTENDED USES OF THE APPLICANT DEVICE CORE PASTE is a dental core buildup material intended to be used with 4th or 5th generation resin adhesive primer/bonding systems. Arm h. Sandate James L. Sandrik, PhD Cosmedent, Inc. 401 N. Michigan Avenue Suite 2500 Chicago, Illinois 60611 Submitted: April 14, 2004 {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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines. JUN - 3 2004 Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 James L. Sandrik, PhD Director of Regulatory Affairs Cosmedent, Incorporated 401 North Michigan Avenue, Suite 2500 Chicago, Illinois 606011 Re: K040994 Trade/Device Name: Core Paste™ Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: April 15, 2004 Received: April 16, 2004 Dear Dr. Sandrik: Wc have reviewed your Section 510(k) premarket notification of intent to market the device we nave to read 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 Interstate commerce prior to shay are been reclassified in accordance with the provisions of Amendinent, or to act read Cosmetic Act (Act) that do not require approval of a premarket the Federal 1 000, Drag, than Coou may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions of a 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 (1 Nr.), it may of subject to tack of Federal Regulations, Title 21, Parts 800 to 898. In your device ean be found in ther announcements concerning your device in the Federal Register. {2}------------------------------------------------ Page 2 -- James L. Sandrik, PhD 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 premainter 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), nlease contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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, Culs Chiu S. Lin, PhD 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 12040994 510(k) Number (if known): Device Name: MULTIPLE (CORE PASTE) Indication For Use: • Dental core buildup material for use with 4th or 5th generation resin adhesive primer/bonding systems. × Prescription Use (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 (ODF) Swati Dunne Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 510(k) Number: K011964