FDA Advises Against Use of Rite-Dent Products
FDA Advises Against Use of Rite Dent Products The United States Food and Drug Administration (FDA) has issued an advisory to health care professionals to discontinue using dental products made by Rite Dent Mfr Corp. Under a court order
FDA Advises Against Use of Rite-Dent Products
The United States Food and Drug Administration (FDA) has issued an advisory to health care professionals to discontinue using dental products made by Rite-Dent Mfr Corp. Under a court order obtained by the FDA issued in relation to problems with the firm’s manufacturing methods, in early January U.S. Marshals seized all dental devices at the company’s Hialeah, Fla., facility.
Dental products seized include Alginate Impression Material, Ultra Impression Material, Enamel Bonding System, Pit and Fissure Chemical Curing Sealant, Tooth Shade Resin material, Cavity Varnish, Polycarboxylate (PCA) Cement, and Zinc Phosphate Cement. Value of the seized products is $208,910 according to an FDA statement, which notes it also uncovered “significant deficiencies” in Rite-Dents’ manufacturing processes. Those deficiencies were said to possibly affect safe and effective use of the products.
In November 2010, the FDA inspected Rite-Dent’s Hialeah facility and discovered what it called “continuing significant deviations” from the current good manufacturing practice requirements for the products. The FDA established the requirements to ensure safety and effectiveness among medical devices.
The inspection further revealed Rite-Dent’s Ultra Impression System lacked FDA clearance and marketing approval, and that when the company made a “correction” to its Alginate Impression System it failed to notify the agency. Rite-Dent had received warnings about these violations from the FDA as far back as 2005.
Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, notes, “The FDA expects medical device producers to follow good manufacturing practices and to obtain clearance or approval of the devices they market.” Shuren adds that officials will take “appropriate action” to protect public health when firms do not comply.
In a warning letter issued in 2005 to Rite-Dent President Oscar Lopez, DDS, the FDA’s Florida District Director Emma Singleton outlined 17 points the company had failed to meet in accordance with the administration’s Quality System Regulations. The violations ranged from failure to establish and maintain documentation to establishing and conducting quality audits.
As of February 15, the company’s website, rite-dent.com, was live and had at least one page posted—however, none of the links on that page appeared operational. On that same date attempts by Dimensions to contact Oscar Lopez for comment by telephone at Rite-Dent’s Hialeah office were turned away at the switchboard.
Source: Food and Drug Administration, Dimensions of Dental Hygiene
