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Visioner 21-A

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

510(k) K901037

Visioner 21-A is a Class I device made by J. Morita U.S.A., Inc, cleared under FDA 510(k) K901037 on 14 Aug 1990, 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 NumberK901037 Date14 Aug 1990ClearedStatusActive

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  • Withdrawn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
J. Morita USA, Inc.
Device class
Class I
Regulation
21 CFR Part 872.4565
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

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

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