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Ekonic Dental/Medical Mask (Md 610)

by Ekonic Company, Ltd.

510(k) K970440

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 NumberK970440 Date27 Mar 1997ClearedStatusActive

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  • Withdrawn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)

510(k) Number
FDA Product Code
FXX
Device Class
Class II
Regulation
21 CFR Part 878.4040
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 EKONIC DENTAL/MEDICAL MASK (MD 610) is a device intended for use in dental and medical settings as a barrier protection mask. It is designed to provide protection against fluids and particulates during clinical procedures.

This mask is supplied non-sterile and is intended for single-use. It is authorized under FDA 510(k) clearance K970440 with product code FXX and was determined to be substantially equivalent to a predicate device. The device is manufactured by Ekonic Company, Ltd. and is intended for use in general and plastic surgery environments.

Questions

AI-generated answers, 23 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 EKONIC DENTAL/MEDICAL MASK (MD 610) used for?

    The EKONIC DENTAL/MEDICAL MASK (MD 610) is intended for use in dental and medical settings as a barrier protection mask to provide protection against fluids and particulates during clinical procedures, including in general and plastic surgery environments.

  • Is the EKONIC DENTAL/MEDICAL MASK (MD 610) sterile or non-sterile, and is it reusable?

    The EKONIC DENTAL/MEDICAL MASK (MD 610) is supplied non-sterile and is intended for single-use only, meaning it should be discarded after one procedure to maintain barrier integrity and prevent cross-contamination.

  • What regulatory authorization does the EKONIC DENTAL/MEDICAL MASK (MD 610) have?

    The EKONIC DENTAL/MEDICAL MASK (MD 610) is authorized under FDA 510(k) clearance K970440 with product code FXX and was determined to be substantially equivalent to a predicate device.