The FDA has recently granted 510(k) clearance to a medical device called Buzzy developed by Pain…
Tag: FDA 510k clearance
Incisive Technologies Receives FDA Clearance for BlueCheck Caries Detection and Monitoring
Australia: Incisive Technologies has announced that its first product, BlueCheck™ Caries Detection and Monitoring, has received…
SprintRay Introduces the High Impact Denture Base into their Digital Denture Workflow
SprintRay has announced the attainment of FDA 510(k) clearance for their latest product, the High Impact…
Overjet’s Dental AI Wins Fast Company’s 2023 World Changing Ideas Awards
Overjet has been recognized with Fast Company's 2023 World Changing Ideas Awards for using innovative technology…
DESS Offers FDA-Compliant Workflow for Dental Labs
DESS Blanks and Ti-Bases by DESS have achieved PNP FDA accreditation, making it possible for dental…
DEXIS Receives FDA Clearance for DTX Studio Clinic
DEXIS has announced that , DTX Studio Clinic has received FDA 510(k) clearance for AI findings…
OrthoFX introduces NiTime Aligners, the First FDA-Cleared Nighttime-Only Aligner System
OrthoFX announced that their NiTime Aligners have received 510(k) clearance from the U.S Food and Drug…
Overjet’s AI-Powered Caries Assist Aids Caries Detection
Caries Assist by Overjet is a AI-powered dental caries detection and outlining software for chairside aid…
V-Print Splint Comfort 3D Print Resin by VOCO Cleared by FDA
VOCO has received FDA 510k clearance for its V-Print Splint Comfort 3D print resin, which produces…