Subject: Verification of Dental Materials and Statement of Assurance

Thank you for your interest regarding the dental materials and practices that we use at the lab to provide dental laboratory services. We proudly assure you that 100 percent of the work that you receive from us is fabricated in the United States by our skilled staff of dental technicians.

We fabricate thousands of PFM and all-ceramic restorations everyday at our dental laboratories in California. Glidewell Laboratories (http://www.glidewelldental.com) is located at 4141 MacArthur Blvd. in Newport Beach, Calif. BDL Prosthetics is just down the street at 2181 Dupont Drive in Irvine, Calif. (http://www.bdlprosthetics.com).

Our Newport facility is home to our state-of-the-art dental operatory where Dr. DiTolla and the staff of the Glidewell Education Center are working to provide dentists with AGD PACE-approved continuing education, and Chairside®, a magazine featuring articles of special interest to dentists. Our Irvine facility provides such industry standards as BioTemps® temporaries, Silent Nite® anti-snore appliances, PlaySafe® mouthguards, Simply Natural Dentures™ and Simply Natural Partials™.

From the initial March 2008 media report that first aired on a local TV station, there was concern that dental work caused a Columbus, Ohio, patient to experience an adverse reaction because the porcelain in her bridge contained lead. Initially, there was a considerable amount of China-bashing and concern about outsourcing; however, the reporting raised questions about materials used in the U.S. to fabricate dental restorations.

We use only FDA-registered dental materials to fulfill your prescriptions for dental laboratory services. No dental materials that we use to fabricate custom porcelain and metal crowns & bridges, temporaries and removable appliances, for example, list lead in their compositions. Moreover, there are no fabrication processes that we use at the lab that involve the use of lead.

Even so, could there be a trace amount of lead in dental ceramic, and if so, does it present a danger to your patients? A manufacturer of widely recognized brand name materials for dental use responded as follows:

In reference to recent questions concerning lead in dental prosthesis, we believe the “Solubility Test” conducted in accordance with ISO 6872 is the standard for testing safety of dental prosthesis in the mouth. In standardized solubility tests in accordance with ISO 6872, there is no detectable level of lead from any Ivoclar Vivadent alloy or ceramic.

The ADA asked the FDA (Food and Drug Administration) and the CDC (Centers for Disease Control and Prevention) to explain “the level of lead reported in the crown in media reports—approximately 200 parts per million,” and interpret the results of tests that the ADA is conducting. ADA President Mark Feldman said, “I’m relived that the CDC sees no threat to patients based upon the trace amount of lead reported.”(Furlong A. Lead risk level low. ADA News 2008 May; 39(9):1,12.)

We are ready to provide you access at any time to any information that you request concerning the materials and processes that are used to fulfill your work orders. For example, we have MSDS sheets for all of the dental materials that we use. MSDS sheets are public knowledge, are also available from the manufacturers of the dental products that labs use to make crowns, bridges, dentures, etc., and oftentimes are accessible over the web.

The lab is in full compliance with all state, federal, and local laws, business practices, and dental industry manufacturing practices. All dental devices are fabricated according to your instructions and dental material manufacturers’ instructions for use. All dental devices are fabricated to your order, subject to your approval and acceptance, in accordance with the terms and conditions of the lab’s limited warranty (which is printed on the reverse to the lab’s work order).

We believe that all providers of dental laboratory services must be transparent about where their work is made and straightforward about the materials and fabrication methods used to fulfill your work orders. We understand doctors’ concerns and hope this letter will grant you peace of mind as you prescribe future restorations for your patients.

(Form Date: May 2008)