Quality System Audits

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DLMS believes that quality is one of the most important issues that any medical device manufacturer should address, so we go far above and beyond what is required by regulatory authorities.

The DLMS distribution facility in Scottsdale Arizona, which warehouses and distributes our products in North America, employs a state-of-the-art qualty management system which exceeds the standards and requirements of the Food and Drug Administration and Health Canada.   To insure the highest standards of quality, DLMS periodically hires outside independent medical device quality systems auditors to conduct formal third-party inspections and reviews of our facilities, records, systems, quality manual, procedures and records.

Our superior quality systems are also regularly reviewed by our largest customers as part of their auditing processes. 

CE European Union

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Crystal Ultra material is certified for distribution in Europe and other countries around the world that recognize the CE mark and the related EC-certificate as a full quality assurance system.

"The CE marking with the Notified Body Numbers 0297 may be affixed on teh devies listed in the certificate." 

The CE mark indicates that the product complies with European Union regulatory controls and legislation which enables transportation and use of the products within the European Economic Area.

ISO 13485 Medical Manufacturing

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Crystal Ultra is manufacturered in Germany in a facility that special-purpose certified as a ISO 13485 Medical Manufacturing facility specifically for the purpose of "Design, manufacture and sale of dental materials based on resins, glasses, ceramics and cements, auxiliar agents and accessories.

DLMS conducts periodic on-site and remote audits and inspections of the manufacturing facilities and processes to insure the highest standards of quality.

Additionally, the facilities and processes are their compliance with ISO 13485 stanards are certified annually by DQS Medizinproduckte GmbH, a German UL-registered firm specializing in certification of German quality management systems.   The facility was certified according to the newest 2012 version of the ISO 13485 standard in November of 2013.

Additional information about the manufacturing processes are confidential, but if you would like more information, please use our contact us form.

US FDA Registered

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

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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

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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

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CE CERTIFIED

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IDENTCERAM

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SAFETY DATA

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