faq

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Frequently Asked Questions

PAYMENT

What payment methods does Ortho-Cycle Co., Inc. accept?

All transactions are in U.S. dollars. We accept Visa or MasterCard only.
Please send the necessary information with the order form and sign for authorization. Unless otherwise agreed, we will charge your card before shipping the processed order. Payments may be sent by draft or wire transfer from abroad, but extra charges will be applied due to bank fees.
Overdue Balance Policy: After 30 days, a 5% late fee will be applied to the unpaid balance.

I accept your offer for my attachments, when you will send the check?

Payment will be made within 30 days from receipt, unless special arrangements are made.

SHIPPING

How to mail my orthodontic attachments for reconditioning to you?

Complete the order form for reconditioning service, You can send your attachments in "as is" condition (i.e. ligated on arch wires and/or with pins), please spray a chemical disinfectant that is used in the office and enclose the attachments in a puncture-resistant container.
Shipping: UPS is our carrier of choice for domestic and international shipping, but also US Postal Service (Express Mail), if required.
All shipping expenses (i.e. postage, insurance, along with a $2.00 charge for handling) are paid by the customer.
All shipments, domestic and international are insured to the value of the content.
Orders shipped outside the United States: Your local government or carrier may charge an import, customs, duty, or brokerage fee. These fees are out of the control of Ortho-Cycle Co., Inc. and vary based on your local government and carrier requirements. Ortho-Cycle is not responsible for any import and/or customs fees that may be incurred.

PRIVACY POLICY

We appreciate the trust you place in Ortho-Cycle Co., Inc. and would not want to jeopardize your trust in any way. We respect your privacy and are committed to protecting the security of your personal information. Rest assured that we will not rent or sell your personal information to any third party.

What information does Ortho-Cycle Co., Inc. collect?

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.

How does Ortho-Cycle Co., Inc. use my information?

Our primary goal in collecting personal information from you is to facilitate efficient transactions for products and services.

Is my information secure?

We maintain physical, electronic and procedural safeguards designed to protect personal information. We limit access to personal information to authorized personnel who need access to perform their job and are contractually required to keep your information secure.

How am I updated on Ortho-Cycle Co., Inc.'s privacy policy?

As business conditions change, we will update this policy to reflect changes in our business practices. We will post revisions to our policy on our web site.

FDA AND REPROCESSING SINGLE USE DEVICES


Is reprocessing singleĀ use devicesĀ safe and legal?

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.

What is a 510(k)?

A 510(k) is a pre-marketing notification made to the FDA to demonstrate that the device to be marketed is as safe and effective as (i.e. substantially equivalent to) a legally marketed device that is not subject to pre-market approval (PMA).

Do I need patient consent to use reprocessed single use devices?

The FDA considers reprocessed devices as substantially equivalent to new devices and therefore no special consent form is required. General patient consent for a procedure covers the facility's prerogative to select devices as they see fit. Only investigational devices require special patient consent.

Why do manufacturers label devices "for single use only"?

The decision to label a device as single use is at the discretion of the manufacturer and is not driven by the FDA. The decisions by the manufacturer to label a product as single use takes into account both product performance and financial considerations (increasing revenue).

Questions and Comments

Please feel free to send your privacy-related comments or questions to OrthoCycle@aol.com or write: Ortho-Cycle Co., Inc., 2026 Scott Street, Hollywood, FL 33020. You may also call our office at 954.920.9074 or toll free at 1.800.82.CYCLE.