Skip to content

Valo 5971-D

by Ultradent Products, Inc.

Ref 5971-D

Valo 5971-D 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 11 May 2026 (Basic UDI-DI 0883205-TF112AP), cleared under FDA 510(k) K190627 on 29 Apr 2019 and listed in FDA GUDID since 21 Aug 2025 (UDI-DI 00883205041906), active as of 24 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K190627

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0883205-TF112AP Basic UDI-DI 00883205041906UDI-DIDate11 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00883205041906 UDI-DI Date21 Aug 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK190627 Date29 Apr 2019DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0883205-TF112AP registered 11 May 2026 Active
  • FDA 510(k) K190627 decided 29 Apr 2019 Active
  • FDA GUDID UDI-DI 00883205041906 listed 21 Aug 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K190627
  2. Listed FDA GUDID 00883205041906
  3. Registered EUDAMED 0883205-TF112AP

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  • Withdrawn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 GRAND Corded Curing Light EUDAMED
Valo GUDID
Generic name
Dental/surgical polymerization lamp
Model / Ref / Catalog
5971-D
Primary DI / UDI-DI
00883205041906
Basic UDI-DI
0883205-TF112AP
510(k) Number
FDA product code
EBZ
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
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 (K190627)

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
  • Convenience kit
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)