Ortho-Cycle Co.

Description

It is a leading international company focused on reconditioing orthodontic attachments and is continously building on its strengths for over 36 years. As part of its strength, Ortho-Cycle Co., Inc is the first and only company in its field that has been certified by ISO 9001:2008; 13485:2003 and CE Mark.

Ortho-Cycle. is the first (and only one) company in its field that has been certified ISO 9001:2008, 13485:2003 and CE Mark. Our customers' trust in us for over 30 years certifies our high quality and our dedication to quality.

As part of providing you with our products and services, we obtain personal information about you, such as your name, address, email and phone number.

It is Ortho-Cycle Co.'s quality policy to provide our customers with services that comply with requirements while meeting or exceeding their needs and expectations for performance, reliability and safety at a competitive cost.

The FDA requires that devices are clean and sterile as well as safe and effective (substantially equivalent) for their intended use as the devices were when they were new. The FDA conducts inspections of reprocessors twice as frequently as device manufacturers. In other words, not only are the reprocessors considered to be the manufacturer of the device when they reprocess it, they must adhere to even stricter standards than the manufacturers. In addition, the FDA oversees and regulates the practice of reprocessing with significant oversight from Congress. Therefore, reprocessors must submit 510(k)s and receive clearance from the FDA.

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