CDT Dental Lab Quality Management 2

Question 1

Which document serves as the primary reference for establishing a dental laboratory quality management system in the United States?

Accepted Answer

ISO 13485:2016

Answer

ISO 13485:2016 specifies requirements for a quality management system for organizations involved in the design and manufacture of medical devices, including dental prosthetics.

Question 2

A dental lab receives a crown back from the dentist because the margin is open. Which corrective action step should come FIRST?

Accepted Answer

Document the nonconformance in the complaint log

Answer

Documenting the nonconformance is the first step in any corrective action process to ensure traceability and proper root cause analysis.

Question 3

What is the purpose of a 'design history file' (DHF) in a dental laboratory producing custom appliances?

Accepted Answer

To document the design and development process for regulatory compliance

Answer

A design history file documents the design and development process to demonstrate that the device was developed in accordance with the approved design plan.

Question 4

A technician notices that a batch of alloy from a new supplier has inconsistent color after casting. What QMS tool should be used to identify the root cause?

Accepted Answer

Fishbone (Ishikawa) diagram

Answer

A fishbone diagram systematically maps potential causes across categories such as materials, methods, machines, and manpower to identify root causes.

Question 5

Under FDA regulations, which type of dental prosthetic is classified as a Class II medical device requiring 510(k) clearance?

Accepted Answer

Removable partial denture frameworks

Answer

Removable partial denture frameworks are classified as Class II devices under 21 CFR Part 872 and require 510(k) clearance before marketing.

(CDT) Certified Dental Technicians Practice Test

(CDT) Certified Dental Technicians Practice Test

CDT Dental Lab Quality Management 2