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Valo 5182-

by Ultradent Products, Inc.

Valo 5182- is a Class II device made by Ultradent Products, Inc., cleared under FDA 510(k) K220471 on 22 Feb 2022 and listed in FDA GUDID since 11 Mar 2025 (UDI-DI 00883205032980), 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) K220471

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 Number00883205032980 UDI-DI Date11 Mar 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK220471 Date22 Feb 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K220471 decided 22 Feb 2022 Active
  • FDA GUDID UDI-DI 00883205032980 listed 11 Mar 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K220471
  2. Listed FDA GUDID 00883205032980

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  • Withdrawn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
5182-
Primary DI / UDI-DI
00883205032980
510(k) Number
FDA product code
EBZ, EAQ, PEQ
GMDN term
Dental/surgical polymerization lamp
Device class
Class II
Regulation number
872.6070, 872.6350, 880.6320
GUDID distribution status
In Commercial Distribution

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Properties

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