Search for: U.S. Food and Drug Administration

BIOLASE Epic Hygiene Dental Laser Receives Cellerant Award

BIOLASE, Inc. (NASDAQ: BIOL), the global leader in dental lasers, announced that its Epic Hygiene dental...

Lipella Pharmaceuticals Announces Creation of Oral Health Scientific Advisory Board

Lipella Pharmaceuticals (“Lipella” or the “company”), a clinical-stage biotechnology company addressing serious diseases with...

Desktop Health Receives FDA Clearance for SmileGuard Resin

Desktop Health announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance...

Exocad Releases Exoplan 3.0 Galway Software in the United States

exocad, an Align Technology, Inc. company, and a leading dental CAD/CAM software provider, has...

NYU Dentistry Performs First Dental Student-led Robot-assisted Dental Implant Surgery

Dental students at NYU College of Dentistry became the first in the U.S. to...

VideaHealth Dental AI Solution Receives FDA 510(k) Clearance

VideaHealth, a dental AI pioneer, has announced the U.S. Food and Drug Administration (FDA)...

X-Guide Dynamic Navigation Receives FDA 510(k) Clearance To Aid in Minimally Invasive Endodontic Procedures

X-Nav Technologies, LLC, a leading creator of image-guided and robot-assisted surgical products, announced that...

SoftSmile Announces FDA 510(k) Clearance for AI Powered Software VISION

SoftSmile, a leading medical technology company based in NY, and developer of advanced orthodontic...

FDA Grants 510(k) Market Clearance to Vivos Therapeutics’ mmRNA Oral Appliance for Treating Mild to Moderate Sleep Apnea

Vivos Therapeutics, Inc. (the “Company” or “Vivos”) (NASDAQ: VVOS), a medical technology company focused...

FDA Revises NSAID Label Warning

The U.S. Food and Drug Administration (FDA) is strengthening an existing label warning that...