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Tri Auto ZX2

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

510(k) K170275

Tri Auto ZX2 is a Class I device made by J. Morita U.S.A., Inc, cleared under FDA 510(k) K170275 on 11 Sep 2017, 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 NumberK170275 Date11 Sep 2017ClearedStatusActive

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  • Withdrawn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

cited in the FDA summary

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

Cites

Cited by

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

Devices cleared under K170275

2 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K170275
UDI-DISize and differences
J. MORITA MFG. CORP. TR-ZX2 Type PLUS
J.MORITA MFG.CORP.
TR-ZX2 Type PLUS04548213055999 —On the market
Tri Auto ZX2 TR-ZX2
J.MORITA MFG.CORP.
TR-ZX204548213027064 —On the market

Similar devices

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

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