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Ultrapro TX Cordless 5739-

by Ultradent Products, Inc.

Ultrapro TX Cordless 5739- is a Class I device made by Ultradent Products, Inc., cleared under FDA 510(k) K211531 on 17 Dec 2021 and listed in FDA GUDID since 27 May 2023 (UDI-DI 00883205035462), 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) K211531

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 Number00883205035462 UDI-DI Date27 May 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK211531 Date17 Dec 2021DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K211531 decided 17 Dec 2021 Active
  • FDA GUDID UDI-DI 00883205035462 listed 27 May 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K211531
  2. Listed FDA GUDID 00883205035462

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Ultrapro TX Cordless
Generic name
Dental surgical power tool motor, electric
Model / Ref / Catalog
5739-
Primary DI / UDI-DI
00883205035462
510(k) Number
FDA product code
EKX
GMDN term
Dental surgical power tool motor, electric
Device class
Class I
Regulation number
872.4200
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental surgical power tool motor, electric

Cleared under the same submission (K211531)

and 8 more cleared under K211531

Similar devices

Other devices filed under FDA product code EKX (Handpiece, direct drive, ac-powered).

Other devices from Ultradent Products, Inc.

See all devices from Ultradent Products, Inc. →

Properties

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