FIRST SPEP

{0}------------------------------------------------ #### KO12032 510(k) SUMMARY This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92 Trade Name: Common Name: #### First Step BRACKET ADHESIVE RESIN AND TOOTH CONDITIONER Classification Name: #### BRACKET ADHESIVE RESIN AND TOOTH CONDITIONER 21 CFR 872.3750 ## Description of Applicant Device: A two bottle, self-etching primer for use with light-curing and self-curing direct bonding orthodontic adhesives. # Intended Uses of Applicant Device: Intended to be used primarily for etching and priming of enamel for the application of an orthodontic attachment. ### Predicate Device: Transbond™™ Plus Self Etching Primer # Scientific Concepts and Significant Performance Characteristics: | | FIRST STEP | Transbond™ Plus<br>Self Etching Primer | |---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | A self-etching primer for use with<br>light-curing and self-curing direct<br>bonding orthodontic adhesives. | A self etching primer for use only<br>with light-curing direct bonding<br>orthodontics adhesives | | Chemical<br>Composition | Combination of an acid and<br>methacrylate. | Combination of an acid and<br>methacrylate. | | Mechanical/<br>Physical<br>Properties | • Combines etching and priming in<br>one easy step<br>• No rinsing<br>• Etch and primes simultaneously<br>• Outstanding bond strengths | • Combines etching and priming in<br>one easy step<br>• No rinsing<br>• Etches and primes simultaneously<br>• Outstanding bond strengths | {1}------------------------------------------------ 510(k) Submission for First Step Bisco, Inc., 1100 W. Irving Park Road Schaumburg, IL. 60193 # 510(k) SUMMARY, continued This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92 Side by side comparisons of First Step to the predicate device Transbond™ Plus Self Side by Side Compansons of Free Stop to the production with the equivalent to the legally marketed device. Shear bond strength testing results were reviewed. Based on the resting it Shear bond strength testing rocalle wore rottenes the predicate device and therefore has proven its safety and efficacy. Kathy Joung, Ph.D 1-800-BIS-DENT or 847-534-6106 Fax: 847-891-6865 June 25,2001 {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 SEP 1 7 2001 Ms. Kathy Long Director of Quality Systems Bisco. Incorporated 1100 West Irving Park Road Schaumburg, Illinois 60193 Re: K012032 Trade/Device Name: First Step Regulation Number: 872.3750 Regulation Name: Adhesive, Bracket and Tooth Conditioner Accessory Regulatory Class: II Product Code: DYH Dated: June 25, 2001 Received: June 29, 2001 Dear Ms. Long: 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. 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. {3}------------------------------------------------ Page 2 - Ms. Long 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 (section 531-542 of the Act; 21); CFR 1000-1050. This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please 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 807.97). 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. y. Quintero Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ 510(k) Submission for First Step Bisco, Inc., 1100 W. Irving Park Road Schaumburg, IL. 60193 # Indications for Use 510(k) Number (if known): Not Applicable KO12037 First Step Device Name: Indications for Use: A two bottle, self-etching primer for use with light-curing and self-curing direct bonding orthodontic adhesives. (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) OR | Concurrence of CDRH, Office of Device Evaluation (ODE) | | |--------------------------------------------------------|--| |--------------------------------------------------------|--| Prescription Use (Per 21 CFR 801.109) Over-the-Counter Use_ (Optional Format 1-2-96) Susan Ruano (Division Sign-Off) (Division of Dental, (Division Sign-Off) Division of Dental, Infection Control, Division of Dental, Infection Devices Division of Dental, finese and Gevicess and General Hospital Devices and General Hoof 10 000004