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Ledx-Pro 90.10.2403

by Orthometric – Indústria e Comércio de Produtos Médicos e Odontológicos Ltda

Ledx-Pro 90.10.2403 is a Class II device made by Orthometric – Indústria e Comércio de Produtos Médicos e Odontológicos Ltda, cleared under FDA 510(k) K131042 on 3 Oct 2013 and listed in FDA GUDID since 5 Apr 2023 (UDI-DI 07908611204455), active as of 12 Nov 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 12 Nov 2026

Documents

510(k) K131042

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07908611204455 UDI-DI Date5 Apr 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK131042 Date3 Oct 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K131042 decided 3 Oct 2013 Active
  • FDA GUDID UDI-DI 07908611204455 listed 5 Apr 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K131042
  2. Listed FDA GUDID 07908611204455

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Ledx-Pro
Generic name
Dental/surgical polymerization lamp
Model / Ref / Catalog
90.10.2403
Primary DI / UDI-DI
07908611204455
510(k) Number
FDA product code
EBZ
GMDN term
Dental/surgical polymerization lamp
Device class
Class II
Regulation number
872.6070
GUDID distribution status
In Commercial Distribution

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Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)