Search Results
Found 1 results
510(k) Data Aggregation
K Number
K113334Device Name
AVEX CX2 AND AVEX CXI2 CERAMIC BRACKETS
Manufacturer
Date Cleared
2012-02-03
(81 days)
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
OPAL ORTHODONTICS BY ULTRADENT PRODUCTS INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
AVEX® CX2 and AVEX® CXi2 Ceramic Brackets are intended for use in Orthodontic treatment.
Device Description
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.
Ask a Question
Ask a specific question about this device
Page 1 of 1