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Root Zx II

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

510(k) K071190

Root Zx II is a Class I device made by J. Morita U.S.A., Inc, cleared under FDA 510(k) K071190 on 17 Aug 2007, 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 NumberK071190 Date17 Aug 2007ClearedStatusActive

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  • Withdrawn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

Devices cleared under K071190

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 K071190
UDI-DISize and differences
Root ZX II Canal Measurement Module DP-ZX
J.MORITA MFG.CORP.
DP-ZX04548213013227 —On the market
ROOT ZX II OTR Module DP-ZX-VL
J.MORITA MFG.CORP.
DP-ZX-VL04548213022519 —On the market

Similar devices

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

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

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  • Veraview X800

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  • Root ZX3

    Class II

  • I-Dixel

    Class II

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