FDA WARNING_LETTER - Sybron Dental Specialties - October 02, 2012

The FDA issued a Warning Letter to Sybron Dental Specialties, Inc., and Ormco Corporation on July 17, 2012, regarding the Insignia software. The FDA learned the firm was marketing the Insignia software in the U.S. without marketing clearance or approval, violating the Federal Food, Drug, and Cosmetic Act.

The Office of Compliance reviewed Ormco Corporation's website and product catalog, determining the Insignia software is a device under section 201(h) of the Act. The device is adulterated under section 501(f)(1)(B) because the firm lacks an approved premarket approval application (PMA) or an approved investigational device exemption (IDE). The FDA previously received a 510(k) premarket notification for the Insignia software but determined it was (b)(4) and issued a letter indicating the device was (b)(4) and (b)(4).

The FDA requires the firm to immediately cease distribution of the Insignia software and take prompt action to correct the violations. Failure to comply may result in regulatory actions including seizure, injunction, civil money penalties, and federal agencies being advised when considering contracts. The firm must respond in writing within fifteen business days, detailing specific corrective steps, prevention plans, and documentation. If corrections require more time, a timetable must be provided. The response should be sent to Dr. Cesar A. Perez. The