SILVER SPRING, Md., Jan. 13, 2011 /PRNewswire-USNewswire/ —
U.S. Marshals, acting under a court order sought by the U.S. Food
and Drug Administration, on Jan. 5 and 6, seized all dental devices
from Rite-Dent Manufacturing Corporation, located in Hialeah, Fla.
The seizure of dentistry products valued at $208,910 follows an
FDA inspection that found significant deficiencies in the company’s
manufacturing processes that may affect the safety and
effectiveness of the products.
The seized products 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,
all used in the practice of dentistry. FDA inspections of the
Rite-Dent facility, most recently in November 2010, revealed
continuing significant deviations from the current good
manufacturing practice requirements for the products. Good
manufacturing practice requirements help to ensure the safety and
effectiveness of medical devices.
FDA’s recent inspection also confirmed that the company had not
obtained FDA marketing approval or clearance for a device called
the Ultra Impression System.
The company also failed to notify the FDA regarding a correction
it made to a device called the Alginate Impression System.
The FDA previously warned the company about these and similar
violations during FDA inspections in 2005, March 2010, and May-June
2010, as well as in a 2005 Warning Letter.
The FDA advises health care professionals to discontinue use of
“The FDA expects medical device producers to follow good
manufacturing practice and to obtain clearance or approval of the
devices that they market,” said Jeffrey Shuren, M.D., Direct