Internal Hex Dental Implant System Gets FDA Clearance

Richard Gawel

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Southern Implants North America has received 510(k) clearance from the Food and Drug Administration for its PROVATA internal hex dental implant system, making it commercially available for sale in the United States for the first time.

The PROVATA is designed to complement the company’s External Hex Implant with an internal hex connection. Available in standard, the Co-Axis with Subcrestal Angle Correction and PROMAX ultra-wide implant designs offer tools to address a variety of clinical cases.

Clinicians can maintain flexibility, reduce costs, and simplify their inventory with the PROVATA, Southern Implants says. The dental implant interface only requires two prosthetic connection diameters and one surgical kit for both the internal and external hex systems while maintaining the company’s SInergy Surface and Grade 4 CP titanium (≥900 MPa).

“I have used PROVATA in more than 200 cases and believe having both internal hex for the simplicity and external hex for more complex cases with one surgical kit makes it the most flexible system in the world,” said Dr. Pär-Olov Östman, a clinician in Sweden.

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