Practice Test Geeks(CIT) Certified Implantology Technician Practice Test
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Regulatory Compliance & Standards Flashcards

7 cards from real CIT practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.

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

    Answer: Class III (Premarket Approval)

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

  2. Which ISO standard specifically governs dental implants and their components?

    Answer: ISO 14801

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

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

    Answer: Premarket Approval (PMA) Application

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

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

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

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

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

    Answer: Food and Drug Administration (FDA)

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

  6. What is the primary purpose of a Design History File (DHF) in implant device regulation?

    Answer: To record all design and development activities for a device

    The DHF contains records demonstrating that the device design was developed in accordance with the approved design plan and FDA requirements under 21 CFR 820.30.

  7. Under OSHA's Bloodborne Pathogens Standard, which practice is required when handling used implant components?

    Answer: Universal precautions with appropriate PPE

    OSHA's Bloodborne Pathogens Standard (29 CFR 1910.1030) requires universal precautions treating all human blood and OPIM as infectious, necessitating appropriate PPE.