Powerball Screw System Receives FDA 510(k) Clearance

HAWTHORNE, N.J. - EntSun -- Xcell Dental Implant today announced that its Powerball Screw System has received 510(k) clearance from the U.S. Food and Drug Administration, marking a major regulatory milestone for clinicians seeking a more predictable prosthetic screw solution in implant dentistry.

The Powerball Screw System addresses one of the most important mechanical challenges in implant prosthetics: maintaining stability at the prosthesis–abutment interface while supporting safe, predictable management if mechanical complications occur. The system was engineered around a core clinical philosophy: protect the implant, protect the multi-unit abutment, and make prosthetic complications easier to manage.

"FDA 510(k) clearance represents a major step forward for the Powerball Screw System," said Dr. Jonathan M. Abenaim, DMD, DABOI, founder and developer. "In full-arch implant dentistry, screws are critical engineering links between the prosthesis and the patient's implants. Our goal was to create a screw system that gives clinicians confidence, stability, and retrievability when it matters most."

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Designed with attention to preload stability, prosthetic fit, screw-access visibility, and controlled mechanical behavior, the Powerball system supports precise engagement with multi-unit abutments and is intended for use within digitally designed and milled prosthetic workflows.

"The mouth is a high-force environment," Dr. Abenaim added. "Powerball was created with the understanding that if failure ever occurs, it should be manageable, visible, and retrievable — not catastrophic."

This FDA clearance marks a regulatory milestone for a product with over ten years of active clinical use, trusted by restorative dentists, prosthodontists, oral surgeons, periodontists, and dental laboratories nationwide.

About Xcell Dental Implant
Xcell Dental Implant is a dental technology company founded by Dr. Jonathan M. Abenaim, DMD, DABOI, focused on developing clinically driven innovations for implant dentistry.

Media Contact:
Jonathan Abenaim, Owner and CEO
Xcell Dental Implant
Phone: 973-423-4460
Email: doctor@needteethnow.com
http://thepowerballscrew.com

Regulatory Note: The Powerball Screw System has received FDA 510(k) clearance for use in implant prosthetic dentistry.