Navigation Links
U.S. Marshals Seize Dental Devices From Florida Manufacturer
Date:1/13/2011

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.  

(Logo:  http://photos.prnewswire.com/prnh/20090824/FDALOGO)

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 these products.

"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., Director of FDA's Center for Devices and Radiological Health.  "If firms ignore these requirements, we will take appropriate action to protect public health."

For more information:


Media Inquiries: Doug Karas, 301-796-2805, Douglas.Karas@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA




'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Federal Agents Seize FastSize Extenders and FastSize EQM™ Erectile Quality Monitors
2. Biosites Triage Products Seized by Beijing Customs; Chinese Market Facing Shortage
3. United States Seizes Unapproved Ozone Generators
4. Edge EHR Corp. Announces edgeDMS for iPad, Native Touch-Based Clinical Charting Software for the Paperless Dental Office.
5. Reportlinker Adds European Markets for Dental Bone Graft Substitutes, Dental Membranes and Tissue Engineering 2011
6. Reportlinker Adds Asia-Pacific Dental Devices Market Outlook to 2016
7. Dental Implant Market in Canada Experiences 5.6% Growth in 2009 While US Market Declines by 4.2%
8. Henry Schein Inc. Donates Equipment to ADA Community Dental Health Coordinator Pilot Program
9. Reportlinker Adds Canadian Dental Market Overview & Dentist Survey 2010 (Implants, Prosthetics, Imaging & CAD/CAM)
10. DentalXChange Endorsed by California Dental Association
11. LifeNet Health and Salvin Dental Specialties Announce Partnership
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/2/2016)... -- Allergan plc (NYSE: AGN ), a leading ... announced Accelerated Share Repurchase (ASR) Program. Logo - ... , ... announced, the Company entered into a variable tenor ASR arrangement ... $10 billion of its ordinary shares. Approximately 40.5 million shares ...
(Date:11/30/2016)... , Nov 30, 2016 ... "US Market Overview for Neuromodulation, Neurovascular, Neurosurgical and Monitoring Devices ... ... The full report suite on the ... fluid external drainage systems, intracranial pressure monitoring devices, detachable coils, ...
(Date:11/30/2016)... , Nov. 30, 2016 Varian Medical Systems ... named America,s Most JUST Company in the Healthcare Equipment ... Forbes magazine,s inaugural "JUST 100 List." The rankings ... largest surveys ever conducted on attitudes towards corporate behavior, ... inaugural list ranks U.S companies against their peers within ...
Breaking Medicine Technology:
(Date:12/2/2016)... ... December 02, 2016 , ... ... Dothan-Wiregrass Area in Alabama are expected to attend the UNCF Dothan-Wiregrass Mayor’s Luncheon ... provide scholarship funds for area students and operating support to UNCF-member institutions, including ...
(Date:12/2/2016)... ... 02, 2016 , ... U.S. Surgeon General, Dr. Vivek Murthy, graces the cover ... he was inspired to practice medicine at an early age by his father, who ... making diagnoses and prescribing medicine,” he states. “It is about building relationships with people; ...
(Date:12/2/2016)... ... December 02, 2016 , ... Mediaplanet is ... USA Today, which covers the innovative treatments, therapeutic technologies, and revolutionized nutrition that ... “We are prolonging life 6 years in the last 3 decades,” says Dr. ...
(Date:12/2/2016)... ... December 02, 2016 , ... Rijuven Corp launches rejiva ( http://www.rejiva.com ), a ... No other wearable health technology on the market can deliver all that rejiva can. ... meaningful insights about their health than the usual heart rate and steps taken”, adds ...
(Date:12/2/2016)... ... December 02, 2016 , ... Today CloudMine, a secure, cloud-based ... named the best Sales Team of 2016 as part of the 2016 SIIA ... the Software & Information Industry Association (SIIA), the principal trade association for the ...
Breaking Medicine News(10 mins):