Regulatory Updates: Page 73

FDA clears MPowRx antisnoring device
By DrBicuspid.com staff writers
MPowRx Health and Wellness Products has received 510(k) clearance from the FDA to begin marketing its MPowRx Snoring Solution device in the U.S., the company announced.
September 17, 2009
Michelson Diagnostics gets CE Mark for OCT system
By DrBicuspid.com staff writers
Michelson Diagnostics has received the European CE Mark for its VivoSight optical coherence tomography scanner, enabling its clinical use in Europe for the diagnosis, monitoring, and treatment of oral and other cancers.
September 16, 2009
HIPAA now requires breach notification
By DrBicuspid.com staff writers
The U.S. Department of Health and Human Services has issued new regulations requiring healthcare providers, health plans, and other entities covered by the Health Insurance Portability and Accountability Act to notify individuals when their health information is breached.
August 24, 2009
Milestone Scientific gets notice of allowance on patent
By DrBicuspid.com staff writers
The U.S. Patent and Trademark Office has issued a notice of allowance to Milestone Scientific for its U.S. patent application directed to the use of a disposable handpiece for fluid administration.
August 23, 2009
Spectra caries detection device gains FDA clearance
By DrBicuspid.com staff writers
The U.S. FDA has granted marketing clearance to Air Techniques for its Spectra optical caries detection device.
August 19, 2009
2009 08 20 14 57 04 896 2009 08 20 Spectra
Lawyer recommends reporting drug-induced xerostomia to FDA
By DrBicuspid.com staff writers
Dentists should report cases of xerostomia caused by medications to the FDA, Edwin Zinman, D.D.S., J.D., told attendees at the World Congress of Minimally Invasive Dentistry annual meeting.
August 18, 2009
Biolase gets Waterlase marketing approval in China
By DrBicuspid.com staff writers
Biolase Technology has received approval to sell its Waterlase dental laser systems in China. The official medical device registration certificate granted by the Chinese State Food and Drug Agency comes after many years of hard work, rigorous testing, and analysis of the product, according to the company.
August 11, 2009
State audit cites Texas dental board shortcomings
By Kathy Kincade
A report released this week by the Texas State Auditor's Office takes the State Board of Dental Examiners to task for failing to adequately regulate dental licenses and keep the public informed of complaints.
August 5, 2009
2009 08 06 09 10 16 394 Texas Capitol 70
FDA issues guidance document on amalgam
By DrBicuspid.com staff writers
The U.S. FDA has issued its new guidance document on amalgam, "Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy."
August 4, 2009
AGD supports FDA ruling on dental amalgam
By DrBicuspid.com staff writers
The Academy of General Dentistry (AGD) supports the U.S. FDA's ruling last week that dental amalgam is a safe and effective dental restorative material, the organization announced.
August 3, 2009
California fights aerosol transmissible diseases
By DrBicuspid.com staff writers
The California Occupational Safety and Health Administration has recently adopted a new regulation to prevent aerosol transmissible diseases at healthcare facilities, according to the California Dental Association.
July 30, 2009
Kerr issues statement on FDA amalgam ruling
By DrBicuspid.com staff writers
Kerr Dental has issued a statement regarding the U.S. FDA's recent decision to classify dental amalgam as a class II medical device.
July 29, 2009
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