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Valo 5891

by Ultradent Products, Inc.

Part of a family of 20 devices: see the family page

Ref 5891

Valo 5891 is a device classified as Class I in the EU and Class II in the US made by Ultradent Products, Inc., registered in EUDAMED on 20 May 2026 (Basic UDI-DI 0883205-TF370BF), cleared under FDA 510(k) K220471 on 22 Feb 2022 and listed in FDA GUDID since 24 Feb 2024 (UDI-DI 00883205034182), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K220471

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0883205-TF370BF Basic UDI-DI 00883205034182UDI-DIDate20 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00883205034182 UDI-DI Date24 Feb 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK220471 Date22 Feb 2022DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0883205-TF370BF registered 20 May 2026 Active
  • FDA 510(k) K220471 decided 22 Feb 2022 Active
  • FDA GUDID UDI-DI 00883205034182 listed 24 Feb 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K220471
  2. Listed FDA GUDID 00883205034182
  3. Registered EUDAMED 0883205-TF370BF

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
VALO X TransLume Lens EUDAMED
Valo GUDID
Generic name
Dental/surgical polymerization lamp
Model / Ref / Catalog
5891
Primary DI / UDI-DI
00883205034182
Basic UDI-DI
0883205-TF370BF
510(k) Number
FDA product code
EBZ, EAQ, PEQ
EMDN code
Z12119003 Cold light dental equipment
GMDN term
Dental/surgical polymerization lamp
Device class
Class I EUDAMED
Class II GUDID
Regulation number
872.6070, 872.6350, 880.6320
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Dental/surgical polymerization lamp

Cleared under the same submission (K220471)

and 8 more cleared under K220471

Similar devices in this category

Other devices filed under VARIOUS DENTAL STOMATOLOGY INSTRUMENTS.

Other devices from Ultradent Products, Inc.

See all devices from Ultradent Products, Inc. →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (22, all answered No)