Skip to content

Tri Auto Zx

by J. Morita U.S.A., Inc

510(k) K970339

Tri Auto Zx is a Class I device made by J. Morita U.S.A., Inc, cleared under FDA 510(k) K970339 on 4 Jun 1997, active as of 8 Nov 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 8 Nov 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK970339 Date4 Jun 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  • Withdrawn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
EKX
FDA applicant
J. Morita USA, Inc.
Device class
Class I
Regulation
21 CFR Part 872.4200
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Related clearances

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Similar devices

Other devices filed under FDA product code EKX (Handpiece, Direct Drive, Ac-Powered).

Other devices from J. Morita U.S.A., Inc

  • Lubrina 2

    Class I

  • Veraview X800

    Class II

  • Root ZX3

    Class II

  • I-Dixel

    Class II

See all devices from J. Morita U.S.A., Inc →