ZERAMEX® XT(tapered) is FDA Cleared as the First 100% Metal-Free, Two-Piece Ceramic Implant with Internal Connection

Unique ceramic implant solution now FDA approved for sale in the US. ZERAMEX® XT(tapered) is now available as the first 100% metal-free, two-piece ceramic implant with internal connection.

Miami, FL, December 26, 2018 --(PR.com)-- Patients increasingly indicate that they prefer metal-fee solutions for dental implants as they seek to mimic the look and biological compatibility of natural teeth. ZERAMEX® XT offers patients the biological, soft tissue and esthetic benefits of ceramic implants with the modern design and ease of use of a two-part implant with a cement-free internal connection and tapered body.

DentalPoint, the pioneer in two-piece ceramic implants has received FDA approval for their latest product – ZERAMEX® XT. The ZERAMEX® XT system is a 100% metal free alternative to titanium implants designed for highly cosmetic tooth replacement, especially in the esthetic zone. Dental professionals will now be able to use a two-piece ceramic implant with a reversible screwed internal connection that supports a natural soft-tissue appearance. ZERAMEX® XT was developed for outstanding soft-tissue attachment and low inflammatory response.[i] The white zirconia material especially benefits patients with a thin mucosal biotype.[ii] Zirconia implants demonstrate a low affinity to plaque[iii] and studies have shown that microcirculatory dynamics in peri-implant mucosa around zirconia are comparable with those around natural teeth.[iv]

The ZERAMEX® XT ceramic implant is manufactured from high-strength ceramic Bio-HIP ATZ. The hard zirconia material with the color and translucence of natural teeth is manufactured by hot isostatic pressing. No thermal process (sintering) or post-processing takes place after the final shaping of the outer and inner geometry of the implant. This ensures that a high degree of precision is achieved, and no further changes can occur in the material structure.

ZERAMEX® XT offers greater restorative flexibility compared to one-piece or cemented ceramic implants. The reversible screwed internal connection is a unique differentiation to existing systems on the market. The extremely hard ceramic is combined with an ultra-strong, high-performance carbon fiber screw. The VICARBO® screw is 100% metal-free and stabilizes tensile forces. Risk of excess cement during the procedures which are often associated with soft tissue inflammation and the development of peri-implantitis can be avoided.[v]

“ZERAMEX® XT is a breakthrough in the development of an equal performing ceramic implant compared with traditional implants. But on top of that it offers all the benefits based on the material. We are convinced that ZERAMEX® XT is the right product to answer the recent trend of patient preferring metal-free dental implants.” - Adrian Hunn, VP Marketing & Sales DentalPoint AG, Zurich, Switzerland.

The implant shape and thread design of ZERAMEX® XT have been developed to achieve high primary stability. The ZERAFIL™ surface is a micro-structured implant surface that enables decisive osseointegration of the dental implants. The success rate of ZERAMEX® ceramic implants with a ZERAFIL™ surface is between 96.7 and 98.5 percent, depending on the system, and bears witness to the decisive osseointegration thanks to the optimum surface structure.[vi] The hydrophilic implant surface ZERAFIL™ is sandblasted and etched so that osteoblasts can grow directly up to the dental implant and firm adhesion to the implant surface is achieved. The ZERAMEX® XT ceramic implant is placed 1.6 mm supracrestally (optionally up to 0.6 mm) and offers great prosthetic flexibility. The implant thread was developed to achieve high primary stability. The reservoir for bone chips at the implant tip simplifies the placement of the implant.

ZERAMEX® XT and ZERAMEX® P6 systems are available for sale through distribution partner, Emerginnova. Michael Foley, President of Emerginnova, says “XT allows implant clinicians to confidently offer ceramic implants to meet their patients demands while respecting the most modern designs, workflow and treatment planning that they expect.” First customer shipments are scheduled for December 14th. Introductory launch packages, including loaner use of surgical kits are now available for pre delivery purchase.

Contact: Michael Foley

[i] Cionca N, Hashim D, Mombelli A. Zirconia dental implants: where we are now, and where are we heading? Periodontol 2000 2017; 73(1):241-258

[ii] Cosgarea R, Gasparik C, Dudea D, et al. Peri-implant soft tissue colour around titanium and zirconia abutments: a prospective randomized controlled clinical study. Clin Oral Implants Res 2015;26(5):537-544

[iii] Cionca N, Hashim D, Mombelli A. Zirconia dental implants: where we are now, and where are we heading? Periodontol 2000 2017; 73(1):241-258
Scarano A, Piattelli M, Caputi S, et al. Bacterial adhesion on commercially pure titanium and zirconium oxide disks: an in vivo human study. J Periodontol 2004;75(2):292–296

[iv] Kajiwara N, Masaki C, Mukaibo T, et al. Soft tissue biological response to zirconia and metal implant abutments compared with natural tooth: microcirculation monitoring as a novel bioindicator. Implant Dent 2015;24(1):37-41

[v] Wilson TG Jr. The positive relationship between excess cement and peri-implant disease: a prospective clinical endoscopic study. J Periodontol 2009;80(9):1388-1392

[vi] Chappuis V, Cavusoglu Y, Gruber R, Kuchler U, Buser D, Bosshardt DD.
Osseointegration of Zirconia in the Presence of Multinucleated Giant Cells. 2016 Aug;18(4):686-98. doi: 10.1111/cid.12375. Epub 2015 Sep 17.
Michael Foley