This was a very exciting week at Dale Dental as we finally unveiled the long-awaited authenticity labels now included with every Coral Optical Zirconia understructure.
Unlike any label before, these labels clearly state USA country-of-origin manufacture, compliance with the Food and Drug Administration’s GMPs and ISO 9001:2008 certification manufacturing.
Our customers have been asking for this, so I hope it was worth the wait. This new system is advanced on so many levels and we’ve already received some exciting feedback in the first week since we started. Everyday Coral is becoming a smarter and smarter choice for dentist and dental labs and it’s going to continue getting even better.
Here’s the text from the press release:
Coral Optical Zirconia Understructures
Answer the Five Ws of Patient Safety
with New and Imroved Labeling
Introducing the dental industry’s first forgery-proof authenticity label to disclose country-of-origin manufacture,
FDA compliance and ISO certification for a dental restoration.
Richardson, Texas (Nov. 5, 2010) - Coral Optical Zirconia understructures are the industry’s first dental restoration to include Medical Marks authenticity labels that disclose country-of-origin manufacture, FDA compliance and ISO certification with every case. These forgery-proof labels, designed to increase patient safety and ensure manufacturing transparency, are now included at no extra charge with all Coral Optical Zirconia brand restorations from Dale Dental.
“We are answering the who, what, where, why and when of medical device labeling and patient safety,” said Dale Dental, CDL, President and Founder David Lesh, CDT. “Patients, dentists and our laboratory partners want complete transparency about what materials are used to manufacture their dental restorations, who manufactured the restoration, where it was manufactured and the compliant environment in which it was manufactured. That’s what we’re giving them with Coral zirconia understructures and we’re the only ones doing it in a forgery-proof, completely reliable way.”
Coral Optical Zirconia understructures are now the world’s first dental restoration to provide positive, label-based, forgery-proof identification of being manufactured in the U.S. at an ISO 9001:2008 certified laboratory that is in full compliance with the U.S. Food and Drug Administration’s good manufacturing process requirements. These two-part labels contain unique codes that are activated only after being attached to a specific case. They feature advanced online verification for the dentist and dental laboratory, so each can be confident they are getting the restoration ordered, made in the USA with the brand prescribed.
Fraudulent material usage and country-of-origin manufacturing disclosure have become of heightened concern since traces of lead were found in U.S. dental restorations shipped to an American dentist from an offshore dental laboratory. In the interest of patient safety, the National Association of Dental Laboratories has recently begun urging federal and state agencies to adopt model legislation requiring country-of-origin labeling as well as other material disclosures. Several states already require such disclosures.
“At Dale Dental, we are at the forefront of disclosure labeling, going beyond what is required to offer complete transparency to our customers and their patients. It’s not just what they expect, it’s what they deserve,” Lesh said.
About Coral Optical Zirconia
Coral Optical Zirconia restorations are available to all dentists exclusively through their dental laboratory. More information about Coral restorations can be found at www.CoralCrowns.com or by calling Dale Dental at 888-Get-Dale.
About Medical Marks
Medical Marks is the world’s first label-based authenticity system designed to help dental laboratories and dentists comply with regulations requiring country-of-origin disclosure and FDA good manufacturing process compliance. For more information about Medical Marks authenticity labeling, contact Dale Dental at 888-Get-Dale.
About Dale Dental
Dale Dental began in 2000, marking the dawn of a new era in dental outsourcing. As America’s first dedicated outsource lab, Dale Dental quickly grew into an unmatched national powerhouse and outsourcing super-center, satisfying a genuine need among dental labs for access to the best proven restorative technologies with the fastest turnaround times at affordable prices. By providing fast market access to the best restorative technologies delivered by a best-of-the-best staff, Dale quickly became synonymous with the industry’s highest quality and consistency and the most efficient manufacture of dental restorations. For more information about the company, contact Dale Dental at 888-Get-Dale.
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This is great information to know about the dental labs and the products that I am getting. Thanks. Dentist Los Angeles
Thanks for the post, good read!