Xcelerate — Your FDA compliance partner

Are you a Milling Center or a Dental Laboratory struggling to get your final medical devices FDA cleared?

If your answer is yes, look no further, Xcelerate has the Solution!

Xcelerate PNP WORKFLOW

Xcelerate Blanks and Xcelerate Ti-Bases are now PNP FDA accredited, allowing your Dental Lab or MC to produce FDA compliant final products without being FDA registered nor having a QMS in place.

To know more please contact us.

The Dental Laboratory industry is increasingly utilizing CAD/CAM automated manufacturing techniques. Meanwhile, the FDA is reviewing and updating Regulatory Requirements for these processes.

Since 2020, products that have 510K FDA certification must be included into a workflow in which each involved technology, product and material must be FDA certified. Final restoration will be FDA approved directly following this production process.

Challenges for Labs and Milling Centers

FDA new regulatory requirements for Ti-Bases and pre-milled blanks on the Digital Workflow has created difficulties for Dental Labs and Milling Centers that are not FDA compliant, causing:

  • Production decrease
  • Customers volume reduction
  • Not having enough product range
  • Miss market quota

Here’s where Xcelerate PNP Workflow comes into place!

Thanks to Xcelerate new FDA accredited Digital Dentistry Workflow, any non-FDA certified Milling Centers and Dental Labs can remain operational.

Xcelerate PNP Workflow Opportunities

Xcelerate PNP Workflow helps many Dental Labs and Milling Centers to stay in business.

  • Provides immediate FDA approval for final products produced with Xcelerate PNP Workflow.
  • Improves Lab operations by being the One-Stop-Shop
  • 30+ connection compatibilities
  • Increases Labs & MC Business Opportunities
  • New Customers acquisition: for being the firsts in offering FDA approved products.
  • Business Growth results

This is hugely positive news for the sector as our certification will help many Dental Labs and MC, not only to stay in business, but to see their business grow.

Being one of the firsts to offer FDA approved final digital products will create a demand that will result in new customers acquisition, which will ultimately help MC and Dental Labs grow their businesses.

How does Xcelerate PNP Workflow work?

By using Xcelerate PNP FDA accredited Premilled Blanks and Ti-Bases and following Xcelerate Digital Solutions IFU, Milling Centers and Dental Laboratories’ final products will be automatically FDA cleared.

Widest portfolio on the market | Industry Pioneers

Xcelerate is the One Stop Shop for many of your FDA product needs! With more than 30 abutment compatibilities, we have the widest range of FDA compliant products on the market!

You’ll be able to produce your own custom abutments in 18 compatibilities with our cleared pre-milled blanks with the most popular CAD CAM options: 3Shape & VHF milling machines.

Components integrated in Xcelerate FDA approved Digital Dentistry Workflow

  • 18 Implant System Compatibilities that include 56 implant platforms: Astra Tech EV, Astra Tech OsseaoSpeed TM , BioHorizons, Biomet 3i Certain®, Biomet 3i OSSEOTITE ®, Camlog, Firadent XiVE, MegaGen AnyRidge, Neodent Grand Morse, NobelActive ®, NobelReplace® / Nobel Prallel Conical, NobelReplace® Trilobe, Nobel Branemark System®, Osstem TS, Straumann® BLX, Straumann® Bone Level, Straumann® Tissue Level, Zimmer Screw-Vent ® / Tapered Screw-Vent®.
  • Scan files from intraoral and desktop scan abutments.
  • 3 shape CAD / CAM software.
  • Ceramic material.
  • Titanium material.
  • VHF Milling machine.
  • Associated tooling and accessories.

Xcelerate PNP ecosystem is constantly growing and evolving to increase the range of materials & products included.

Contact us for a detailed list of actors included in Xcelerate PNP Workflow.

You can purchase all the above Xcelerate products at our shop.

Xcelerate is fully aware that performing a save practice that contributes to the patient’s health and safety is a number one priority for milling centers and dental laboratories, reason why we can assure that Xcelerate FDA 510(k) certification guarantees that any milling center or dental laboratory that follows our Digital Dentistry Workflow with our products, is 100% compliant with FDA policies therefore in accordance with health and safety guidelines. *

(*) Read the Digital Solutions Summary to know the present conditions of the workflow implied. You can also access the IFU. The workflow elements will be always expanded to make sure you are up to date.