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StarDental 266346

by Dentalez, Inc.

StarDental 266346 is a Class I device made by Dentalez, Inc., cleared under FDA 510(k) K251701 on 12 Jan 2026 and listed in FDA GUDID since 1 Sep 2026 (UDI-DI D7022663460), active as of 22 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 22 Oct 2026

Documents

510(k) K251701

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberD7022663460 UDI-DI Date1 Sep 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK251701 Date12 Jan 2026DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K251701 decided 12 Jan 2026 Active
  • FDA GUDID UDI-DI D7022663460 listed 1 Sep 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K251701
  2. Listed FDA GUDID D7022663460

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
StarDental
Generic name
Dental surgical power tool motorized handpiece/set, electric
Model / reference
266346
Primary DI / UDI-DI
D7022663460
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 (K251701)

Similar devices

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

Other devices from Dentalez, Inc.

  • StarDental 266340

    Class I

  • StarDental 266341

    Class I

  • StarDental 266347

    Class I

  • StarDental 266650

    Class I

See all devices from Dentalez, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)