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Y stick

by Osada Electric Co., Ltd.

Y stick (21527) is a device classified as Unclassified made by Osada Electric Co., Ltd., cleared under FDA 510(k) K904742 on 17 Dec 1990 and listed in FDA GUDID since 29 Aug 2018 (UDI-DI 04580406870682), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K904742

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04580406870682 UDI-DI Date29 Aug 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK904742 Date17 Dec 1990DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K904742 decided 17 Dec 1990 Active
  • FDA GUDID UDI-DI 04580406870682 listed 29 Aug 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K904742
  2. Listed FDA GUDID 04580406870682

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Endodontic apex locator
Model / Ref / Catalog
Y stick, 21527
Primary DI / UDI-DI
04580406870682
510(k) Number
FDA product code
LQY
GMDN term
Endodontic apex locator
Device class
U
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Endodontic apex locator

Cleared under the same submission (K904742)

and 3 more cleared under K904742

Similar devices in this category

Other devices filed under Endodontic apex locator.

Other devices from Osada Electric Co., Ltd.

  • ST72

    Class II

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    Class II

  • ST106

    Class II

  • ST92

    Class II

See all devices from Osada Electric Co., Ltd. →

Properties

  • Sterilise before use
  • Over-the-counter
Other properties (13, all answered No)