IDEAL 1 ORTHODONTIC BRACKET ADHESIVE

{0}------------------------------------------------ K033703 FEB - 6 2004 # 510(k) SUMMARY DENTSPLY ### NAME & ADDRESS: #### DENTSPLY International 570 West College Avenue P.O. Box 872 York, PA 17405-0872 7171845-7511 777 849-4749 w.dentsplv.com P. J. Lehn Telefax (717) 849-4343 P. Jeffery Lehn CONTACT: November 21, 2003 DATE PREPARED: TRADE OR PROPRIETARY NAME: IDEAL® I ORTHODONTIC BRACKET ADHESIVE CLASSIFICATION NAMF: Bracket adhesive and tooth conditioner resin (872.3750) PREDICATE DEVICES: High-Q-Bond Adhesive Resin Cement K933766 The IDEAL® 1 ORTHODONTIC BRACKET ADHESIVE svstem DEVICE DESCRIPTION: is a two-part light-cure system: an adhesive and a primer. A tooth conditioner is available if desired for the highest stress bonding cases. IDEAL® 1 ORTHODONTIC BRACKET ADHESIVE bonds metal, plastic, and ceraine orthodontic brackets to natural teeth, acrylic teeth, porcelain crowns, or amalgams. The adhesive is packaged in syringes. No mixing is necessary. The primer is packaged in unit dose, self-dispensing capsules. IDEAL® 1 ORTHODONTIC BRACKET ADHESIVE is indicated for INTENDED USE: bonding of orthodontic brackets to natural and artificial tooth surfaces. TECHNOLOGICAL CHARACTERISTICS: All of the components found in the IDEAL® 1 ORTHODONTIC BRACKET ADHESIVE have been used in legally marketed devices or were found safe for dental use. We believe that the prior use of the components of the IDEAL® I ORTHODONTIC BRACKET ADHESIVE in legally marketed devices, the performance data provided, and the similarity of the predicate to the new device support the safety and effectiveness of the IDEAL® 1 ORTHODONTIC BRACKET ADHESIVE 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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized representation of three human figures, depicted as flowing, abstract shapes. The figures are oriented to the right and appear to be connected or overlapping. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FEB - 6 2004 Mr. P. Jeffery Lehn Director of Corporate Compliance & Regulatory Affairs DENTSPLY International 570 West College Avenue P.O. Box 872 York, Pennsylvania 17405-0872 Re: K033703 Trade/Device Name: Ideal®1 Orthodontic Bracket Adhesive Regulation Number: 872.3750 Regulation Name: Bracket Adhesive Resin and Tooth Conditioner Regulatory Class: II Product Code: DYH Dated: November 21, 2003 Received: November 25, 2003 Dear Mr. Lchn: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave revea your 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 microute comments, 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 approvial applisions 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 adultcration. 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 WI ), it har obe of Federal Regulations, Title 21, Parts 800 to 898. In your device ear ro 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 cquivalence determination does not Please be advised that I DA 3 issualled on that your device complies with other requirements mean that FDA nas made a decorminations administered by other Federal agencies. of the Act of ally I edelar statues and registments, including, but not limited to: registration You must comply with an the Act 8 requirements) (1); good manufacturing practice and ifsimg (21 CFR Pat 607), labolity systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality if stories (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Scction 510(k) This letter will anow you to ough management. The FDA finding of substantial equivalence of substantial equivalence of your device to a premiarket notification. The PDF matts 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), If you desire specific advice to: Jour we at (301) 594-4613. Also, please note the regulation prease contact and Other or Some to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain other general missmational and Consumer Assistance at its toll-free Division of Omals 2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Carls 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}------------------------------------------------ ## 703 INDICATIONS FOR USE STATEME (As Required by 21 CFR 807.87(e) 510(K) Number (if known): #### IDEAL® 1 ORTHODONTIC BRACKET ADHESIVE Device Name: Indications for Use: Bonding of orthodontic brackets to natural and artificial tooth surfaces Suvesh Rurr General Hospital sthesiolog trol, Denta 510(k) Number: メ Prescription Use (Part 21 CFR 801 Subpart D) AND/OR ()ver-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)