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Browsing: 510k
Formlabs’ Premium Teeth Resin Garners FDA 510(k) Clearance for Temporary Crowns and Bridges | Image credit: © Formlabs DentalFormlabs Dental’s Premium Teeth Resin, unveiled earlier this…
Boston Micro Fabrication (BMF), a leader in advanced manufacturing solutions for ultra-high precision applications, announced that it has received 510(k) clearance from the US Food and…
Sofwave Medical Receives 510(k) Marketing Clearance for Pure Impact™ Strength and Body Muscle Unit Using PlyoPulse™ EMS Technology
By Medi
SofWave Medical, Ltd.Pure Impact™ with PlyoPulse™ Technology is a direct add-on Body module to Sofwave’s existing FDA-cleared medical aesthetic device platformPlyoPulse™ technology is an EMS (Electrical…
Align Technology Receives US FDA 510(k) Clearance for Invisalign® Palatal Expander System to Address Skeletal and Dental Expansion in Growing Patients, Including Adolescent Patients Who Represent the Majority of Orthodontic Initiations Worldwide
By Medi
Invisalign® Palatal Expanders offer doctors a removable, safe and clinically effective alternative to traditional palatal expanders.Combined with Invisalign First™ aligners, Invisalign Palatal Expanders provide doctors with…
Andrew Technologies Receives FDA 510(k) Clearance for Commercial Version of HydraSolve™ Lipoplasty System
By Medi
IRVINE, CA., December 17, 2012 /PRNewswire/ — Andrew Technologies, LLC has received FDA 510 (k) clearance for the commercially manufactured version of the HydraSolve™ Lipoplasty System,…