CIT Regulatory Compliance & Standards 2

Question 1

Under FDA regulations, dental implants are classified as which device class?

Accepted Answer

Class III (Premarket Approval)

Answer

Dental implants are FDA Class III devices requiring Premarket Approval (PMA) due to their life-sustaining or implanted nature.

Question 2

Which ISO standard specifically governs dental implants and their components?

Accepted Answer

ISO 14801

Answer

ISO 14801 specifies the fatigue test method for endosseous dental implants under dynamic loading conditions.

Question 3

A dental implant manufacturer must submit which document to the FDA before marketing a novel implant system?

Accepted Answer

Premarket Approval (PMA) Application

Answer

Novel Class III dental implants with no predicate device require a PMA application demonstrating reasonable assurance of safety and effectiveness.

Question 4

What does the term 'biocompatibility' refer to in the context of ISO 10993?

Accepted Answer

Ability of a material to perform without eliciting a harmful response in a biological system

Answer

ISO 10993 defines biocompatibility as the ability of a medical device material to perform with an appropriate host response in a specific application.

Question 5

Which regulatory body enforces Good Manufacturing Practice (GMP) for dental implant manufacturers in the United States?

Accepted Answer

Food and Drug Administration (FDA)

Answer

The FDA enforces GMP requirements under 21 CFR Part 820 (Quality System Regulation) for medical device manufacturers, including dental implants.

(CIT) Certified Implantology Technician Practice Test

(CIT) Certified Implantology Technician Practice Test

CIT Regulatory Compliance & Standards 2