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:1/19/2017)... 19, 2017 Pfizer joins ... Milner Therapeutics Consortium   Major research ... Cambridge   The Milner Therapeutics ... ) as a partner to the Milner Therapeutics Consortium. ... the efficient transfer of materials between industry and academia ...
(Date:1/19/2017)... , Jan. 18, 2017  ViewRay, Inc. (Nasdaq: ... first and only clinical MRI-guided radiation therapy system, announced ... of approximately $26.1 million through a private placement ... Management led the financing and was joined by ... LLC and Kearny Venture Partners, and an additional ...
(Date:1/19/2017)... 18, 2017 The Academy of Managed ... Administration (FDA) for its release today of draft ... decision makers can proactively share clinical and economic ... as emerging therapies awaiting FDA approval. ... that AMCP developed during two multi-stakeholder meetings last ...
Breaking Medicine Technology:
(Date:1/19/2017)... ... January 19, 2017 , ... Next week after January 20th, the fear ... political games that circumvent health needs of over 30 million. Many interviews with Dr. ... and needs government public servants were suppose to prioritize. Interviews provided below. ...
(Date:1/19/2017)... ... January 19, 2017 , ... WhoHaha , a digital ... the American Heart Association (AHA) to produce a three-part video series that uses humor ... as part of the launch of AHA’s Healthy For Good™ movement, which is designed ...
(Date:1/19/2017)... ... 19, 2017 , ... Dr. Andrew Lian-Jie Li ... trained Mohs and cosmetic surgeon. After extensive dermatology research training at the National ... in internal medicine at the Emory University and dermatology training at the University ...
(Date:1/19/2017)... Beach, CA (PRWEB) , ... January 19, 2017 ... ... Oral Health, is now offering treatments for patients with sleep apnea and TMJ ... consequences for dental and physical health. Dr. Rassouli provides personalized care to reduce ...
(Date:1/19/2017)... ... January 19, 2017 , ... Rountree Brady Insurance Agency, ... communities throughout eastern Georgia, is embarking on a charity effort to raise awareness ... more Americans every year than anything else, yet risk factors associated with heart ...
Breaking Medicine News(10 mins):