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Micadent Airbrush

by Hampton Research

510(k) K964059

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK964059 Date19 Dec 1996ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Micadent
510(k) Number
FDA Product Code
KOJ
Device Class
Class II
Regulation
21 CFR Part 872.6080
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Micadent Airbrush is a dental airbrush device classified under § 872.6080, designed to roughen surfaces of dental restorations using air-driven particles. It operates in conjunction with articulation paper to identify uneven areas on restorations, aiding in the refinement of dental work.

This device is supplied as a reusable Class 2 dental instrument and is intended for use in clinical settings. It requires no specific sterility beyond standard dental practice protocols and is not MRI-compatible. The device is authorised under FDA 510(k) clearance (K964059) and falls under product code KOJ, regulated under § 872.6080. No additional regulatory markings or certifications are stated beyond its FDA clearance.

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary purpose of the Micadent Airbrush in dental procedures?

    The Micadent Airbrush is designed to roughen surfaces of dental restorations using air-driven particles. When used with articulation paper, it helps identify uneven areas on restorations, allowing dentists to refine and improve the fit and finish of dental work.

  • Is the Micadent Airbrush intended for single-use or reusable applications?

    The Micadent Airbrush is explicitly supplied as a reusable Class 2 dental instrument. It follows standard dental practice protocols for sterility and is meant for repeated use in clinical settings.

  • What regulatory pathway was followed for the Micadent Airbrush, and what does that mean for its use?

    The Micadent Airbrush received FDA clearance through a 510(k) submission (K964059) under the Traditional review pathway, classified as substantially equivalent to a predicate device. This means it meets FDA standards for safety and effectiveness as a dental airbrush under product code KOJ, regulated under § 872.6080.

  • Can the Micadent Airbrush be used in MRI environments, and what are its storage requirements?

    The Micadent Airbrush is not MRI-compatible, so it should not be used in MRI environments. Storage requirements align with standard dental practice protocols, as no additional sterility or handling instructions are specified beyond routine clinical cleaning and maintenance.