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StarDental 266654

by Dentalez, Inc.

StarDental 266654 is a Class I device made by Dentalez, Inc., cleared under FDA 510(k) K153411 on 8 Apr 2016 and listed in FDA GUDID since 18 Sep 2026 (UDI-DI D7022666540), 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) K153411

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 NumberD7022666540 UDI-DI Date18 Sep 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK153411 Date8 Apr 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K153411 decided 8 Apr 2016 Active
  • FDA GUDID UDI-DI D7022666540 listed 18 Sep 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K153411
  2. Listed FDA GUDID D7022666540

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  • Withdrawn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, pneumatic
Model / reference
266654
Primary DI / UDI-DI
D7022666540
510(k) Number
FDA product code
EFB
GMDN term
Dental surgical power tool motorized handpiece/set, pneumatic
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 (K153411)

and 8 more cleared under K153411

Similar devices

Other devices filed under FDA product code EFB (Handpiece, Air-Powered, Dental).

Other devices from Dentalez, Inc.

  • StarDental 266340

    Class I

  • StarDental 266341

    Class I

  • StarDental 266346

    Class I

  • StarDental 266347

    Class I

See all devices from Dentalez, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
  • Serial number
Other properties (11, all answered No)