5fde6eac-9785-4cf5-8193-5083271652a1UpdatePublished32018-07-062017-11-07In Commercial Distribution08033707079972PrimaryGS1LEONE SPAF5920-81F5920-81432167294LEONE SPA1STARTER KIT STEP&SLIDE LOGIC LINE CERAM falsefalsefalsefalsefalsetruetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety InformationtruefalseK09170200058937Orthodontic bracket, ceramicA ceramic device intended to be bonded to a tooth to hold an orthodontic archwire used to apply pressure to the tooth in order to alter the position of the tooth. It typically has a metal (e.g., stainless steel) insert slot for the archwire, which is held in place with an orthodontic archwire/bracket fixation ring. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.falseActiveNJMBracket, Ceramic, Orthodonticfalsefalse