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Valo 5940-D

by Ultradent Products, Inc.

Valo 5940-D is a Class II device made by Ultradent Products, Inc., cleared under FDA 510(k) K110582 on 28 Apr 2011 and listed in FDA GUDID since 27 Sep 2018 (UDI-DI 00883205104939), 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) K110582

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 Number00883205104939 UDI-DI Date27 Sep 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK110582 Date28 Apr 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K110582 decided 28 Apr 2011 Active
  • FDA GUDID UDI-DI 00883205104939 listed 27 Sep 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K110582
  2. Listed FDA GUDID 00883205104939

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Valo
Generic name
Dental/surgical polymerization lamp
Model / Ref / Catalog
5940-D
Primary DI / UDI-DI
00883205104939
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
  • Convenience kit
  • Lot / batch number
  • Serial number
Other properties (11, all answered No)