Valo X

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 6519Ref 5973-DRef 6538Ref 6539

by Ultradent Products, Inc.

Identity

Trade Name: Valo X EUDAMEDFDA UDI
Generic Name: Dental/surgical polymerization lamp FDA UDI
Device Name: Valo EUDAMED
VALO X Black Demo FDA UDI
VALO X Purple FDA UDI
VALO X Black FDA UDI
VALO X Loaner Unit FDA UDI
VALO X Blue FDA UDI
Model / Reference: 6538 EUDAMEDFDA UDI
6539 EUDAMEDFDA UDI
5973-D EUDAMEDFDA UDI
6519 EUDAMEDFDA UDI
5973-DU FDA UDI
Description: VALO X Black Demo FDA UDI
VALO X Purple FDA UDI
VALO X Black FDA UDI
VALO X Loaner Unit FDA UDI
VALO X Blue FDA UDI

Identifiers

Catalog Number: 5973-DU FDA UDI
6538 FDA UDI
6539 FDA UDI
5973-D FDA UDI
6519 FDA UDI
Primary DI / UDI-DI: 00883205042927 EUDAMEDFDA UDI
00883205042934 EUDAMEDFDA UDI
00883205035561 EUDAMEDFDA UDI
00883205042910 EUDAMEDFDA UDI
00883205043320 FDA UDI
Basic UDI-DI: 0883205-TF370BF EUDAMED
510(k) Number: K220471 FDA UDI
FDA Product Code: EBZ FDA UDI
EAQ FDA UDI
PEQ FDA UDI
EMDN Code: Z12119003 COLD LIGHT DENTAL EQUIPMENT EUDAMED
GMDN Term: Dental/surgical polymerization lamp FDA UDI

Classification

Device Class: Class I EUDAMED
Class II FDA UDI
Regulation Number: 872.6070 FDA UDI
872.6350 FDA UDI
880.6320 FDA UDI
Market of Registration: Germany EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental/surgical polymerization lamp

Valo X by Ultradent Products, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Dental/surgical polymerization lamp.

LEDEX — Dentmate Technology Co. , Ltd. · Class II
Flashlite® — Den-Mat Holdings, LLC · Class II
WOODPECKER — Guilin Woodpecker Medical Instrument Co., Ltd. · Class II
WOODPECKER — Guilin Woodpecker Medical Instrument Co., Ltd. · Class II
Coltolux — Coltene/Whaledent Inc. · Class II
Ascent PX Charging Station — CAO GROUP, INC. · Class II
Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class II
D-LUX+ — DiaDent Group International · Class II

Cleared under the same submission

K220471 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Ultradent Products, Inc.

Sources (9)

FDA UDI f1e84971-3852-4bce-86de-b83e97e1742e 36 fields · synced Jul 29, 2026
FDA UDI a1602272-92c9-4ebc-bcc6-b7bac45f8cb9 37 fields · synced May 30, 2026
FDA UDI 25e56fc1-feb1-4f22-9589-843b7ede9e9f 37 fields · synced May 30, 2026
FDA UDI b8b79d3f-d70a-4482-aae9-17d66cf4942c 36 fields · synced May 30, 2026
FDA UDI 3a12e7d0-5124-4027-91ea-e4b707cc11e7 37 fields · synced May 30, 2026
EUDAMED f34a1e6a-06b5-47f6-8b84-528e710259ff 61 fields · synced Jul 11, 2026
EUDAMED efa41bca-1aa6-4209-b516-3122846c871d 61 fields · synced Jul 16, 2026
EUDAMED af43b156-e4c4-4d89-9047-dabe3e50d6c2 61 fields · synced Jul 18, 2026
EUDAMED 5fdf7e6e-7bf6-4948-ab47-418a88a16340 61 fields · synced Jul 29, 2026