6aac36a2-f010-49f3-9624-43c206300f76UpdatePublished32021-02-192019-09-302021-02-18Not in Commercial DistributionD80776432001PrimaryHIBCCD80776432000Unit of UseHIBCCOMNIARCH®76-432-0076-432-00116903307DENTSPLY SIRONA ORTHODONTICS INC.10Base Rx OMNIARCH® 022/LL3 11NT 7AtruetruefalsefalsefalsetruetruefalsetruefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse+1(833)372-8255CustomerService_GAC@dentsplysirona.com46581Orthodontic bracket, metalA metallic device that is bonded to an orthodontic band, or directly to a tooth, to hold an orthodontic wire and/or other appliance (e.g., rubber bands) used to apply pressure to the tooth in order to alter the position of the tooth. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.falseActiveEJFBRACKET, METAL, ORTHODONTICfalsefalse