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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Sybron Dental Specialties 7/17/12


Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 9200 Corporate Boulevard
Rockville MD 20850 


July 17, 2012
Warning Letter
Daniel Even
Sybron Dental Specialties, Inc., & Ormco Corporation
1717 West Collins Avenue
Orange, California 92867
RE: Insignia, refer to CPT1200125 when replying to this letter.
Dear Mr. Even:
The Food and Drug Administration (FDA) has learned that your firm is marketing the Insignia software in the United States without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
The Office of Compliance, in the Center for Devices and Radiological Health, reviewed the website of Ormco Corporation, a subsidiary of Sybron Dental Specialties Inc., at http://www.ormco.com/products/insignia-custom/index.php, and the Ormco Orthodontic Product Catalog, at http://www.ormco.com/downloads/ormco-productcatalog.pdf, for the Insignia software.  This product is a device within the meaning of section 201(h) of the Act because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body.  The device is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g).
FDA received your firm’s premarket notification under section 510(k) of the Act, 21 U.S.C. § 360(k), for the Insignia software on (b)(4). Subsequently, FDA determined that the device is (b)(4).  FDA issued a letter to your firm, dated (b)(4), indicating that the (b)(4).  The letter also noted that, as a result of the (b)(4), the device is (b)(4).  FDA also indicated in that letter that (b)(4).
Your firm should take prompt action to correct the violations addressed in this letter, including an immediate end to distribution of the Insignia software.  Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice.  These actions include, but are not limited to, seizure, injunction, and civil money penalties.  Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts. 
Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again.  Include documentation of the corrections and/or corrective actions (including any systemic corrective actions) that your firm has taken.  If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities.  If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.  
Your firm’s response should be sent to Dr. Cesar A. Perez at the Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, facsimile at (301) 847-8137.  We remind you that only written communications are considered official.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility.  It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA.  Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the product into compliance. 
Sincerely yours,
Steven D. Silverman
Office of Compliance
Center for Devices and
       Radiological Health