(13 days)
In-Ovation™ C is indicated for orthodontic movement of natural teeth, excluding the mandibular bicuspid teeth.
The In-Ovation™ C brackets are bonded to teeth to apply pressure to the tooth, transmitted through a flexible orthodontic wire, to alter the tooth position. The modified orthodontic ceramic bracket has both aesthetic and self-ligating qualities. The modifications were aimed at facilitating easier orthodontic wire placement and removal through self-ligation and enhancing the bonding and debonding characteristics of the bracket.
This document is a 510(k) premarket notification for the In-Ovation™ C orthodontic bracket, seeking substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a study proving the device meets specific performance metrics.
The document states: "The function and performance of the In-Ovation™ C bracket is similar to the predicate. Minor design changes and incorporation of self-ligation are the only modifications made to the Orthodontic Ceramic Brackets (Mystique®) (K042178)." and "All of the materials used in the device have been used in legally marketed DENTSPLY devices. We believe that the modified device is substantially equivalent to the predicate Orthodontic Ceramic Brackets (Mystique®) (K042178)."
This indicates that the submission relies on the substantial equivalence principle, rather than providing data from new performance studies against specific acceptance criteria.
Therefore, I cannot provide the requested information regarding acceptance criteria and studies from 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.