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X-Cube

by Saeshin Precision Co., Ltd. 2 variants

X-Cube is a Class I device made by Saeshin Precision Co., Ltd., cleared under FDA 510(k) K092758 on 21 Sep 2009 and listed in FDA GUDID since 2 Apr 2026 (UDI-DI 08809260475519), 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) K092758

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 Number08809260475519 UDI-DI Date2 Apr 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK092758 Date21 Sep 2009IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K092758 decided 21 Sep 2009 Active
  • FDA GUDID UDI-DI 08809260475519 listed 2 Apr 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K092758
  2. Listed FDA GUDID 08809260475519

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Dental surgical power tool motorized handpiece/set, electric
Model / reference
X-CUBE
Primary DI / UDI-DI
08809260475519
510(k) Number
FDA product code
EBW
GMDN term
Dental surgical power tool motorized handpiece/set, electric
Device class
Class I
Regulation number
872.4200
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K092758)

Similar devices

Other devices filed under FDA product code EBW (Controller, Foot, Handpiece And Cord).

Other devices from Saeshin Precision Co., Ltd.

See all devices from Saeshin Precision Co., Ltd. →

Properties

  • Sterilise before use
  • Serial number
Other properties (13, all answered No)