MISSION VIEJO, Calif., April 25, 2019 /PRNewswire/ --
Dear Medical Professional,
The Food and Drug Administration has implemented regulations for all PDO thread devices that use PDO Threads for soft tissue approximation, requiring a Class II designation. MIRACU PDO THREADS® is the only US FDA Cleared Class II PDO Threads of its kind on the market, with an indication and delivery method designated as a either a syringe needle or cannula, based on the dependability and safety presented for evaluation. MIRACU PDO THREADS® Class II designation is for soft tissue approximation, where use of an absorbable suture is appropriate. The anatomical location(s) of use are on the skin for dermatological applications only.
As you know, there are many PDO Thread companies on the market, who are misleading their medical professional clients with the marketing of their PDO Threads for soft tissue approximation without proper Class II designation and authentic FDA 510K numbers, putting their clients at risk for assuming liability. In addition to the cessation of sales, many have had previous issues with recalls, lack of inventory, challenges with customer service, ultimately leaving medical practices without recourse. Most of these PDO Brands are smuggled from Europe or Asia and repacked here in U.S., posing various issues of quality controls. The entire production process of PDO threads syringes & cannulas are required to be manufactured in an ISO 13485 facility and reviewed by the US FDA for its cleanroom environment, validated sterilization, and overall quality assurance system to maintain its sterility, quality, and efficacy.
MIRACU PDO THREADS® and DBM Corporation, Inc.® offers only the safest and most cutting-edge PDO Thread and Aesthetic Solutions on the market.
DBM Corporation, Inc.®, the official US Representative of MIRACU PDO THREADS® delivers a best in class level of customer service, training, and marketing support. This is validated by a recent survey in which 98% of our customers expressed a high overall satisfaction. With the FDA implementing these regulations, it's important to make sure your practice is only using FDA-cleared PDO Threads. By using MIRACU PDO THREADS® you can be sure to protect your patients, as well as your risk of liability.
"The FDA-clearance for MIRACU PDO THREADS® demonstrates our brand's unwavering commitment to the safety, quality and excellence needed to elevate the standards in the PDO Thread industry," said Ethan Min, CEO of MIRACU USA. "This recognition comes from the FDA, the highest organization in the US. With that, healthcare providers and consumers recognize they can trust MIRACU PDO THREADS® and DBM Corporation, Inc.® to offer only the safest and most cutting-edge PDO Thread and Aesthetic Solutions on the market."
To receive this FDA designation, DBM Corporation, Inc.® proactively worked through a rigorous three-year evaluation process to meet more than 90 validated requirements for our advanced human embedding PDO threads and cannulas, including extensive biocompatibility testing to ensure none of the materials are harmful to patients' when embedded.
If you are currently carrying and offering PDO Threads in your practice, that are not MIRACU PDO THREADS®, please be aware that they are not FDA-cleared, and could pose safety concerns to your patients. To learn more about how to search the FDA Website, visit www.MIRACUUSA.com, or call 1-949-616-8748 to be connected with your local sales representative.
About DBM Corporation, Inc.®
DBM Corporation, Inc.®, headquartered in Mission Viejo, California, is a solution provider for medical aesthetic needs in U.S. market. DBM Corporation, Inc.® is the Official North America Representative of MIRACU, PDO Threads®.
For more information regarding MIRACU PDO Threads®, or to place an order, or attend one of our educational seminars and bootcamps, Please contact DBM Corporation, Inc.®
DBM Corporation, Inc.®
**Any forward-looking statements are subject to risks and uncertainties such as those described in DBM Corporation, Inc.® periodic reports. Actual results may differ materially from anticipated results.**
SOURCE DBM Corporation, Inc.