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Valo 5183

by Ultradent Products, Inc.

Valo 5183 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 20 Aug 2025 (UDI-DI 00883205032997), 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 Number00883205032997 UDI-DI Date20 Aug 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 00883205032997 listed 20 Aug 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K220471
  2. Listed FDA GUDID 00883205032997

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  • Withdrawn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
5183
Primary DI / UDI-DI
00883205032997
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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Other devices filed under Dental/surgical polymerization lamp.

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Properties

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