FDA registration for Crystal Ultra was completed on September 24, 2013.   For more information, click on the documents and links below:

fda-510k-screengrab-300w 

FDA Website

Shippers who are handling FDA-registered materials may need to confirm the FDA registration in the FDA database.  You can do so either by looking up K130654 in the FDA 510(k) Premarket Notification database or by clicking on the link below:

accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm ?ID=K130654

 510k-summary-page1-300w

510(k) Summary

A 510(k) summary was prepared and is available for download at the FDA by clicking on the link below

Download from this site:

pdfK130654-crystalultra-510k-fda-summary.pdf

Download from FDA website:

pdfaccessdata.fda.gov/cdrh_docs/pdf13/K130654.pdf

Upcoming Trade Shows

Please visit Digital Dental at our booth at one of these trade shows this year.

  • Sep 8, 2018 - LMT East  - Philadelphia, PA
  • Sep 26-29, 2018 - AAID - Dallas, TX
  • Sep 28-29, 2018 - IDT - Phoenix, AZ
  • Oct 11-13, 2018 - DLOAC CAD/CAM Expo - Orange County, CA
  • Oct 31-Nov 3, 2018 - ACP - Baltimore, MD
  • Feb 21-23, 2019 - CDS Midwinter - Chicago, IL
  • Feb 22-23, 2019 - LMT Chicago - Chicago, IL
  • Mar 13-16, 2019 - AO - Washington, DC

Crystal Ultra Specs

Physical Property Measurement
 Vickers Hardness (200 p)  710 MPa **
 Modulus of Elasticity 
(Young Modulus)
 10,000 MPa **
 Flexural Strength  175 MPa **
 Compressive Strength  480-500 MPa **
 Density  1.89 g/cm3
 Chemical Solubility  1.29 μg/cm3
 Water Absorption  16.94 μg/mm3
 Water Solubility  0.04 μg/mm3
 Biocompatibility  Confirmed
 Ceramic Filler  70.02% (wt)
 Color Stability  Confirmed
 Shade Consistency  Confirmed
 Surface Finish  Smooth
 Bond Strength  27-37 MPa

FDA LISTED

fda-white-120h

CE CERTIFIED

ce-certified-120h

IDENTCERAM

identceram-120h

SAFETY DATA

msds-120h