Microfill 13

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K022972 ↗

FDA Product Code

EBF

Device Class

Class II

Regulation

21 CFR Part 872.3690

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Vivacap Hr

  Class II

  FDA 510(k) K982460 Active Cleared 24 Aug 1998

• Futura Topcap Non Gamma-2

  Class II

  FDA 510(k) K011801 Active Cleared 16 Aug 2001

• Latit Flow

  Class II

  FDA 510(k) K040465 Active Cleared 20 Jul 2004

• Meridian

  Class II

  FDA 510(k) K131753 Active Cleared 14 Nov 2013

• Microhybrid 12

  Class II

  FDA 510(k) K022974 Active Cleared 22 Nov 2002

• Vivalloy Hr

  Class II

  FDA 510(k) K982458 Active Cleared 24 Aug 1998

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• Is the Microfill 13 designed for single-use or can it be reused in a clinical setting?

  The Microfill 13 is explicitly supplied as a reusable dental chair for clinical use. Since it is not labeled as single-use or sterile, it must be properly cleaned and maintained between patient encounters in accordance with standard dental practice protocols.

• What types of dental procedures is the Microfill 13 intended to support, and how does its design help?

  The Microfill 13 is a dental chair (Product Code EBF) engineered for ergonomic support and adjustable positioning, ensuring patient comfort during a wide range of dental treatments—such as fillings, cleanings, or restorative procedures. Its adjustable features help accommodate various patient sizes and treatment needs.

• How is the Microfill 13 regulated, and what does its FDA clearance status mean for buyers?

  The Microfill 13 holds an FDA 510(k) clearance (K022972) under the Dental Advisory Committee (DE) with a *substantially equivalent* determination, meaning it was deemed comparable to legally marketed predecessors. This clearance confirms it meets FDA safety and performance requirements for dental chairs, but buyers should verify compliance with their facility’s specific protocols.

• Does the Microfill 13 come pre-sterilized, or is it the user’s responsibility to sterilize it before use?

  The Microfill 13 is supplied non-sterile and intended for reusable clinical use. Sterilization is the responsibility of the dental practice, following standard infection control procedures for reusable dental equipment.

• What should buyers consider when storing the Microfill 13 to maintain its functionality and longevity?

  Since the Microfill 13 is a reusable dental chair, buyers should store it in a clean, dry environment away from direct sunlight or extreme temperatures to prevent wear or damage. Regular maintenance, as outlined in the manufacturer’s instructions, will ensure its ergonomic features remain functional for long-term use.