AAO Urges Members to Report DTC-Related Adverse Effects
The AAO is urging members to submit reports of adverse events related to DTC clear aligners to the FDA’s MAUDE database.
Tag: FDA
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Oryx Dental Imaging Product Secures FDA Clearance
Oryx Dental’s cloud-based imaging software has received FDA clearance to be marketed directly to practices.
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GC Holding AG Appoints Per Falk as CEO
GC Holding AG appointed Dr Per Falk as CEO, marking a significant leadership transition as the company celebrates its 103rd anniversary.
Henry Schein Makes Exclusive Distribution Deal With Radic8 Air Purifier Systems in the U.S. and Canada
The addition of Radic8 air purification devices to the Henry Schein portfolio of air management technologies, reinforces the company’s commitment to helping dental professionals provide a safer environment for patients and staff.
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Aerus Active Air Purifier Receives FDA Clearance for Class II Medical Device
The Aerus Medical Guardian with ActivePure Technology works safely 24 hours a day to protect the rooms where it is installed, even when occupied by large numbers of people.
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Some KN95 Masks Lose FDA Emergency Use Authorization
These KN95 masks, manufactured in China, failed to demonstrate at least 95% particulate filtration efficiency in NIOSH testing, meaning they may not provide consistent and adequate respiratory protection.
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FDA Warns Certain NK95 Masks from China May Not Provide Adequate Respiratory Protection
The warning to health care providers comes after additional filtration performance testing conducted by NIOSH amid the COVID-19 pandemic.
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Despite Lab Delays, Employee Shortage, SML Says Supply Chain Continues
SML’s CEO Rob Veis issues a COVID-19 Update regarding the company’s operation status.
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ADA Calls for Ban on Vaping Devices that Fail FDA Regulation
ADA’s new interim policy follows the American Medical Association’s call to ensure the health and safety of consumers
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FDA Approves KeySplint Soft 3D Print Resin
The 3D printing resin for night guards and splints can now be purchased in the United States, following previous availability in Canada and the European Union.
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ADA Calls SmileDirectClub Statement on FDA Petition “Inaccurate”
Today’s statement from ADA President Chad Gehani, DDS, comes in response to SmileDirectClub’s statement last week claiming the ADA’s Citizen Petition to the FDA regarding the company was “declined.”
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FDA Issues New Consumer Update on Orthodontic Treatment with Braces
The consumer update provides consumers with information on how orthodontic treatment with braces has evolved from the “Metal Mouth” days they may remember.
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