MANDIBULAR LIP BUMPER AND LIP BUMPER TUBES

MANDIBULAR LIP BUMPER AND LIP BUMPER TUBES is an FDA 510(k)-cleared medical device (K891775) manufactured by American Orthodontics. This device is classified under the Dental specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on May 10, 1989. Regulation: 8.