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Regulatory Updates
Regulatory Updates: Page 22
Planmed gets FDA OK for new CBCT scanner features
By
DrBicuspid.com staff writers
Planmed has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for new features on its Verity cone-beam CT (CBCT) scanner.
December 6, 2018
Apteryx gets FDA clearance for 3D imaging module
By
DrBicuspid.com staff writers
Apteryx has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the 3D module of its XVWeb imaging service.
December 5, 2018
Owandy gets FDA clearance for 3D imaging system
By
DrBicuspid.com staff writers
Owandy Radiology has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its I-Max 3D wall-mounted, panoramic digital radiography unit.
November 15, 2018
FDA proposes limits on e-cigarette sales to kids
By
Tony Edwards
Electronic cigarettes (e-cigarettes) and their flavor delivering systems, known as pods, will continue to be sold in U.S. stores but only in areas that are off-limits to minors, according to a November 15 directive from U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD.
November 15, 2018
CDC: Teen e-cigarette use rose sharply from 2017
By
Theresa Pablos
The use of electronic cigarettes (e-cigarettes) by middle and high school students may be an epidemic, according to the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention (CDC). More than 20% of high school students report using e-cigarettes on a regular basis, almost double the number from 2017.
November 15, 2018
Bupivacaine liposome gets 2019 CDT code
By
DrBicuspid.com staff writers
The ADA has created a new Code on Dental Procedures and Nomenclature (CDT) for Exparel, a bupivacaine liposome injectable suspension from Pacira Pharmaceuticals.
November 11, 2018
U.S. voters decide on dental-related issues
By
Theresa Pablos
,
Tony Edwards
U.S. citizens headed to the polls on November 6 to weigh in on a number of dental-related issues in the midterm election. Local and state ballot measures ranged from community water fluoridation to the future of soda taxes, and five dentists were elected to the U.S. House of Representatives.
November 6, 2018
Align Technology gets FDA OK for Invisalign with mandibular advancement
By
DrBicuspid.com staff writers
Medical device company Align Technology has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Invisalign treatment with mandibular advancement.
October 30, 2018
Orthocaps aligners get FDA clearance
By
DrBicuspid.com staff writers
Rocky Mountain Orthodontics has announced that the Orthocaps clear aligners have received 510(k) clearance from the U.S. Food and Drug Administration (FDA).
October 28, 2018
3Shape gets new FDA clearance for ortho workflow
By
DrBicuspid.com staff writers
3Shape has received new 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Ortho System clear-aligner workflow.
October 23, 2018
New ADA policy discourages direct-to-consumer lab services
By
DrBicuspid.com staff writers
The ADA has announced a new policy that discourages direct-to-consumer dental lab services because of the potential for irreversible harm to patients.
October 23, 2018
Dental groups urge revamp of licensing process
By
DrBicuspid.com staff writers
Three dental organizations have joined forces to urge state dental boards to eliminate single-encounter, procedure-based examinations on patients during the dental licensure examination and to make other reforms in the licensing process.
October 1, 2018
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