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The Damon 4Clear is a ceramic bracket system intended to aid in the movement of patient teeth during orthodontic treatment.

The device is a ceramic orthodontic bracket which will encompass maxillary and mandibular brackets from 2nd bicuspid to 2m bicuspid. The Damon 4Clear appliance has both aesthetic and self-ligating qualities. The Damon 4Clear is designed with 1) improved open and close functionality and increased corner radius for increased patient comfort, 2) enhanced bracket placement with placement jigs and 3) improved overall bracket performance without changing treatment mechanics, with rotation and torque control similar to other Damon metal brackets. This system is a bondable device for fixed attached orthodontics.

I'm sorry, but based on the provided text, there is no information available about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a 510(k) summary for a medical device (Damon 4Clear orthodontic bracket) seeking clearance from the FDA for substantial equivalence to existing legally marketed devices.

The content focuses on:

• Device Description: What the device is.
• Intended Use: What the device is for.
• Substantial Equivalence Claim: How it is similar to other devices already on the market.
• FDA Clearance Letter: Official communication from the FDA confirming clearance based on substantial equivalence.
• Indications for Use: The specific medical purposes for which the device is intended.

A 510(k) submission generally does not require extensive clinical trials or performance studies with specific acceptance criteria in the same way a Premarket Approval (PMA) would. Instead, substantial equivalence is often demonstrated through comparisons to predicate devices in terms of materials, design, intended use, and performance characteristics. While some performance testing might be conducted to support the substantial equivalence claim, the provided text does not detail any specific acceptance criteria or study results that directly address the points in your request.

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