Regulatory Updates: Page 19

DenMat gets FDA clearance for clear aligners
By DrBicuspid.com staff writers
The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to DenMat for the right to design, manufacture, and sell orthodontic clear aligners to dental professionals and laboratories.
February 23, 2020
2020 02 24 18 29 5311 2020 02 24 Den Mat Aligners 400
Fla. dental board closes investigation into SmileDirectClub
By Melissa Busch
The Florida Board of Dentistry has closed its investigation into SmileDirectClub's business model and marketing practices, landing the clear-aligner company another victory against traditional orthodontics.
February 18, 2020
2019 06 19 15 07 3264 News Ball 400
Implant Direct gets FDA clearance for dental abutment
By DrBicuspid.com staff writers
Implant Direct Sybron International has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Smartbase abutment for dental implants.
February 9, 2020
2020 02 10 21 22 5428 Clearance Stamp 400
NC ends prior dental exam rule
By Melissa Busch
North Carolina has amended its prior-exam rule, allowing public health dental hygienists to perform preventive dental procedures on patients who have not been previously evaluated by a dentist and without a dentist present. The rule change takes effect on February 1.
January 26, 2020
2017 08 07 15 47 24 917 Dental Bib Girl 400
New Calif. law requires lactation accommodations at work
By Melissa Busch
A new California law takes effect on January 1 that requires workplaces to provide certain lactation accommodations for employees. The law also expands protections for nursing mothers and increases penalties for those businesses that fail to comply with the requirements.
December 18, 2019
2016 12 12 14 55 46 670 California Flag 400
ADA calls for ban on vaping products not OK'd by FDA
By Melissa Busch
The ADA took a new, more aggressive stance against vaping and electronic cigarettes on December 16, calling for a total ban on any products that have not been approved for tobacco cessation purposes by the U.S. Food and Drug Administration (FDA).
December 15, 2019
2019 12 16 22 15 2940 Vaping E Cigarette Woman 400
FDA moves to electronic-only device submissions
By DrBicuspid.com staff writers
The U.S. Food and Drug Administration (FDA) now requires medical device premarket submissions to be sent electronically, eliminating the need for multiple paper submissions.
December 12, 2019
2016 09 02 09 36 05 93 Fda Logo V2 400
FDA: No evidence suggesting dental amalgam unsafe
By DrBicuspid.com staff writers
Dental amalgam is safe for patients and clinicians, said scientists from the U.S. Food and Drug Administration (FDA) during a public meeting on November 13 that aimed to discuss the efforts being made to evaluate dental amalgam and metal-containing implants.
November 13, 2019
2018 11 15 23 31 5737 Fda Logo V2 400
Benco won't appeal FTC ruling, Patterson settles
By Melissa Busch
Benco Dental announced that it will not appeal the U.S. Federal Trade Commission (FTC) finding that the dental product distributor and Patterson Companies conspired not to offer discount pricing to dental buying groups. Meanwhile, Patterson Companies announced that it had reached a settlement with the FTC.
November 11, 2019
2018 08 30 18 07 7208 Settlement 400
Petition: Maine dental board not enforcing amalgam law
By DrBicuspid.com staff writers
Three U.S. nonprofits have petitioned the Federal Trade Commission (FTC) to investigate the Maine Board of Dental Practice to ensure it is enforcing the state's fact sheet law about the mercury content in amalgam fillings.
October 31, 2019
2016 10 11 15 50 56 325 Amalgam Filling 400
FDA grants 1st modified-risk claims for smokeless tobacco
By DrBicuspid.com staff writers
The U.S. Food and Drug Administration (FDA) has granted marketing authorization for the first time for eight smokeless tobacco products from Swedish Match USA under its modified risk tobacco product pathway.
October 21, 2019
2018 11 15 23 31 5737 Fda Logo V2 400
SmileDirectClub sues Calif. dental board for harassment
By Melissa Busch
SmileDirectClub has filed a lawsuit against the Dental Board of California, alleging it intentionally harassed the direct-to-consumer clear-aligner company's clinics in a planned effort to hinder its growth. The litigation further fans the flames between the burgeoning industry and traditional orthodontics.
October 17, 2019
2019 10 18 17 04 1697 Lawsuit 400
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