(288 days)
This device is intended for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended to be single use only.
Orthodontic Ceramic bracket, VENUS and ROSE Bracket is an orthodontic bracket attached to teeth to recover aesthetics and function of malocclusion. Made with aluminum oxide, it is attached to teeth and straightens irregular teeth with orthodontic wire installed through the wire's elasticity. It is made with aluminum oxide and seeks smooth movement of orthodontic wire for straightening irreqular teeth and it requires additional rubber ring or ligating wire to fix Wire.
VENUS Bracket no hook type and ROSE bracket have consists of three parts: the first part is the slot for the orthodontic wire; the second part is a round groove that is to hold a wire with an elastic "O" ring; the third part is the base that adheres to the tooth surface. A colored marking on wing part of bracket indicates orientation for placement.
VENUS Bracket with hook type consist five parts: the slot for the slot for the orthodontic wire; the second part is a round groove that is to hold a wire with an elastic "O" ring; the third part is the base that adheres to the tooth surface; forth part is open guide part which serves as a path for movement of device used to open cap ligated to body; last part is different part from other type of models, it has self-ligating Clip to fix the teeth.
These devices are designed for orthodontic use only. The devices intended use for single use only.
The provided text does not contain information about acceptance criteria and a study that proves a device meets those criteria in the context of an AI/ML medical device. Instead, it is a 510(k) summary for orthodontic brackets (VENUS Bracket and ROSE Bracket), establishing their substantial equivalence to a predicate device (ROSA Bracket).
The document details the device's description, indications for use, comparison with a predicate device, and non-clinical performance data (biocompatibility and mechanical properties) to support its safety and effectiveness. It explicitly states that "No clinical performance testing was performed on VENUS and ROSE brackets," which means there would be no study to prove acceptance criteria based on clinical outcomes.
Therefore, I cannot provide the requested table and information as it is not present in the provided text.
§ 872.5470 Orthodontic plastic bracket.
(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.