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Hero 642

by Micro Mega

510(k) K970649

Hero 642 is a Class I device made by Micro Mega, cleared under FDA 510(k) K970649 on 16 May 1997, active as of 22 Oct 2026.

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK970649 Date16 May 1997ClearedStatusActive

Official records

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  • Withdrawn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
EKS
FDA applicant
Micro-Mega
Device class
Class I
Regulation
21 CFR Part 872.4565
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Similar devices

Other devices filed under FDA product code EKS (File, Pulp Canal, Endodontic).

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