Ortho Specialties Incorporated C / Ortho Specialties Inc. / Dentsply / K140807 Trade / /
Event
FDA Phase / /
Facility
General Hospital / New Hampshire Avenue Document Control Center / / /
IndustryTerm
metal archwire slot / metal reinforced slots / reinforced metal / announcements concerning your device / predicate devices / predicate device / manufacturing practice requirements / compositional technology / marketed predicate devices / manufacturing practice / Internet address http /
MedicalCondition
irritation / oral mucosal irritation / /
Organization
Division of Postmarket Surveillance / Food and Drug Administration / General Hospital / Device Evaluation Center for Devices / Respiratory / Infection Control and Dental Devices Office / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / New Hampshire Avenue Document Control Center / CDRH’s office of Surveillance / M.S. Director Division of Anesthesiology / /
Person
Paula Wendland / Silver Spring / Erin I. Keith / Tim Allesee / / /
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration[removed]New Hampshire Avenue