Intro/Quality Assurance Flashcards
General Supervision
supervising dentist available for consult
Personal Supervision
dentist personally diagnoses/authorizes/dismiss patient
General Supervision: Services
removing cement, polishing teeth, pit/fissure sealants, placing/removing temp restorations, taking impressions for study casts
Personal Supervision: Services
rubber dam, matrix bands, prefitting crowns, taking impressions for ortho
QA Programs
FDA, ADA (Scientific Affairs/Standards), ISO
FDA: Medical Devices Class 1
least regulated. floss, toothbrushes
FDA: Medical Devices Class 2
must meet performance standards. amalgam, composites
FDA: Medical Devices Class 3
most regulated; clinical data needed. bone grafting, TMJ prosthesis
ADA Seal
- profession review of consumer products only since 2005. lasts 5 years. voluntary.
ADA - SCDI
Standards Committee on Dental Informatics
ADA - SCDP
Standards Committee on Dental Products
ADA Standards
Established baselines, makes sure manufacturers and dentists are on the same page
ADA Specifications
requirements for physical/mechanical properties, measured
ISO
International Standards Organization - CE symbol indicates compliance