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Macan Model Mc-4A Dental Electrosurgical Unit

by Macan Engineering Co.

510(k) K052622

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK052622 Date9 Dec 2005ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0810-06 FDA Unclassified (pre-2012) initiated 5 Apr 2006

    The product label fails to warn users to use the device on patients with shielded pacemakers only.

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  • Withdrawn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
EKZ
Device Class
Class II
Regulation
21 CFR Part 872.4920
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Other devices from Macan Engineering Co.

  • MC6A

    Class II