ACCELEDENT

{0}------------------------------------------------ ((( )))OrthoAccel Technologies, Inc AcceleDent " System TRADITIONAL 510(k) NOTIFICATION 510(k) Summary- AcceleDent™ System November 15, 2011 This summary of 510(k) substantial equivalence determination is being submitted in accordance with the requirements of 21 CFR part 807.92. | Submitter: | OrthoAccel® Technologies, Inc.<br>8275 El Rio Street, Suite 100<br>Houston, TX 77054<br>Phone: 832-631-1657<br>Fax: 713-583-9972 | |------------|----------------------------------------------------------------------------------------------------------------------------------| |------------|----------------------------------------------------------------------------------------------------------------------------------| Contact: Michael E Kaufman | Device trade name: | AcceleDent™ System | |----------------------|---------------------------------------| | Common name: | Orthodontic appliance and accessories | | Classification name: | Orthodontic Vibratory Accessory | | Classification: | Class II | | Panel: | Dental | | Product code: | OYH | | Regulation number: | 872.5470 | | Predicate device: | The Orthotrainer, K924975 | Device Description: The AcceleDent™ System is an orthodontic accessory for the treatment of tooth malocclusion. AcceleDent™ should be used by patients for twenty minutes per day in conjunction with standard orthodontic treatment with fixed appliances such as braces. The Activator and Mouthpiece assembly is light (2.7 oz or 75 g), comfortable, handsfree, and can be used while multi-tasking or while engaged in a variety of other daily activities. The most commonly reported multi-tasking use by patients was watching television, reading, using the computer, listening to music and doing homework. 510(k) Section 005 Page 1 {1}------------------------------------------------ OrthoAccel" technologies, Inc. AcceleDent™ System TRADITIONAL 510(k) NOTIFICATION #### Intended Use: AcceleDent™ is an orthodontic accessory intended for use during orthodontic treatment. It is used in conjunction with orthodontic appliances such as braces and helps facilitate minor anterior tooth movement. Characteristics Comparison: A comparison of the AcceleDent™ System's indications for use with the predicate device indicates the AcceleDent™ System is substantially equivalent to currently marketed devices according to the following comparison: - The general intended use of the device as an adjunct to orthodontics to facilitate ● tooth movement is the same as the OrthoTrainer. - The indications for use to accelerate tooth movement during standard ● orthodontic treatment is a subset of the broader indications of the OrthoTrainer. - The technological characteristics of the AcceleDent™ are very similar to the . OrthoTrainer. Both are elastomeric devices that are held in the mouth for a sustained period each day. #### Performance Testing: Non-clinical and clinical performance testing completed with the AcceleDent™ System has demonstrated that the device performs safely and as intended. Non-clinical performance testing completed: - Output force testing . - Force testing . - Electromagnetic Compatibility and Electrical Safety . - . Biocompatibility A clinical study was performed to support this 510(k) Notification. The study was performed to determine whether teeth moved faster with standard orthodontics plus the AcceleDent™ device when compared to standard orthodontics plus a sham control. {2}------------------------------------------------ OrthoAccel® Technologies, Inc. AcceleDent™ System TRADITIONAL 510(k) NOTIFICATION Patients were followed at regular intervals to measure the rate of tooth movement until closure was achieved. Safety assessments also included evaluation of root resorption. The results of the study demonstrated that the AcceleDent™ increased the rate of tooth movement when used as an adjunct to conventional orthodontic treatment, and without any significant risks. ### Conclusion: Based on the results of non-clinical and clinical testing, the AcceleDent™ System performs safely, as intended, and is substantially equivalent to the predicate device. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. To the left of the symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion. The text is in all caps and is relatively small compared to the caduceus symbol. ## DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Mr. Michael E. Kaufman Vice President Marketing & Business Development OrthoAccel Technologies, Incorporated 8275 El Rio, Suite 100 Houston, Texas 77054 NOV 1 7 2011 Re: K110661 Trade/Device Name: AcceleDent" System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: OYH Dated: November 9, 2011 Received: November 10, 2011 Dear Mr. Kaufman: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. {4}------------------------------------------------ Page 2 – Mr. Kaufman 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go 10 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, Nh for Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health {5}------------------------------------------------ # Indication for Use K110661 510(k) Number (if known): Device Name: AcceleDent™ System Indication For Use: AcceleDent is an orthodontic accessory intended for use during orthodontic treatment. It is used in conjunction with orthodontic appliances such as braces and helps facilitate minor anterior tooth movement. Prescription Use X (21 CFR Part 801 Subpart D) And/Or Over the Counter Use __ (21 CFR Part 801 Subpart C) (Please do not write below this line; Continue on another Page if needed) Concurrence of CDRH, Office Device Evaluation (ODE) Division Sign-Off 510(k)__ Seser Rnom (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: K110661