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Avex® CX2 ceramic brackets are intended for use in orthodontic treatment.

Avex® CX2 ceramic brackets are intended to be bonded to teeth upon which an orthodontic wire is placed in a slot to re-position the teeth to desired positions. Avex CX2 ceramic brackets are manufactured from polycrystalline alumina (ceramic) material and have a base which has been designed to provide adhesion to the tooth, yet allow for removal when necessary. The raw material has been documented to be biocompatible for its intended contact and duration of contact. There are several other products in the market that have the same indications as these products and the proposed modification does not affect composition, intended use, or indications for use. Opal Orthodontics has followed design control processes outlined in 21 CFR 820.30 and internal procedures to complete our design control procedure and documentation for the Avex CX2. Avex CX2 ceramic brackets are esthetically preferred as ceramic colored arch wires are available and the vision of "metal mouth" is no longer the case for the bracket wearer. These ceramic brackets and certain arch wires are intended to match natural tooth coloring in order to reduce visibility. Avex CX2 ceramic brackets are indicated for use in patients of all ages when prescribed by a dentist or orthodontist.

AVEX® CX2 and AVEX® CXi2 Ceramic Brackets are intended for use in Orthodontic treatment.

AVEX® CX2 and AVEX® CXi2 ceramic brackets are intended to be bonded to teeth, upon which an orthodontic wire is placed to move the teeth to desired positions. AVEX® CX2 and AVEX® CXi2 Ceramic brackets are manufactured from polycrystalline alumina (ceramic) material and have a base which has been designed to provide maximum adhesion to the tooth, yet allow for easy and complete removal when necessary. The brackets incorporate a water soluble color placement dot as an indicator for correct selection of brackets for each tooth. AVEX® CX2 and AVEX® CXi2 are the exact same brackets except AVEX® CXi2 has a stainless steel 17-4 insert inside the archwire slot will facilitate archwire movement without force and preventing "notching" of the slot.