FDA.reportPublic FDA data

Valo X

Primary DI
00883205043344
Brand
Valo X
Company
ULTRADENT PRODUCTS, INC.
Model
5973-DU
Catalog number
5973-DU
Device description
VALO X Black Demo
Published
2026-08-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
EAQDetector, Ultraviolet
EBZActivator, Ultraviolet, For Polymerization
PEQAccessories To Examination Light

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EAQDetector, UltravioletDental2
EBZActivator, Ultraviolet, For PolymerizationDental2
PEQAccessories To Examination LightGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220471000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220471000VALO X, VALO X Accessory LensesUltradent Products, Inc.2022-02-22EBZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00883205043344PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00883205043344008832050433448832050433440883205043344

GMDN Terms#

Term, Definition table
TermDefinition
Dental/surgical polymerization lampA mains electricity (AC-powered), hand-held, device intended to be used to activate the polymerization of: 1) a dental resin-based material in the oral cavity; and/or 2) a surgical adhesive/sealant during an open-surgery procedure. It typically includes a light source [e.g., halogen, fluorescent, light-emitting diode (LED)] that emits light in the visible, or less frequently, ultraviolet spectrum, mounted in a handpiece that is typically attached to or used with a portable control unit or charging station.

Contacts#

Phone, Email table
PhoneEmail
801-572-4200customerservice@ultradent.com

Regulatory Flags#

DUNS number
013369913
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00883205026286Ultrapro TxS8303S83032026-08-22
00883205029102OpalDam1824-U1824-U2026-08-22
00883205029119OpalDam1825-U1825-U2026-08-22
00883205029126OpalDam1826-U1826-U2026-08-22
00883205029133OpalDam324-U324-U2026-08-22
00883205029140OpalDam325-U325-U2026-08-22
00883205029157OpalDam326-U326-U2026-08-22
00883205041005Thermo Clone606560652026-08-22
00883205041883UltraCem205620562026-08-22
00883205043221ViscoStat Clear640764072026-08-22
00883205043238ViscoStat Clear640864082026-08-22
00883205043245ViscoStat Clear640964092026-08-22
00883205043252ViscoStat Clear641064102026-08-22
00883205031976STARbrush109310932024-12-07
00883205040398Halo Sectional Matrix System588358832026-06-26
00883205040978Halo Sectional Matrix System588258822026-06-26
00883205044617Halo Sectional Matrix System993199312026-06-26
00883205044624Halo Sectional Matrix System993299322026-06-26
00883205044631Halo Sectional Matrix System993399332026-06-26
00883205044648Halo Sectional Matrix System993599352026-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
E22190701TwinWaveVOCO GmbHEBZ2026-08-18
006522211493673M™ Ortholux™3M UNITEK CORPORATIONEBZ2026-04-25
006522211493743M™ Ortholux™3M UNITEK CORPORATIONEBZ2026-04-25
006522211493813M™ Ortholux™3M UNITEK CORPORATIONEBZ2026-04-25
08809455602515Demi ProMETA SYSTEMS CO., LTD.EBZ2026-04-22
08809455602522Demi ProMETA SYSTEMS CO., LTD.EBZ2026-04-22
08809455602539Demi ProMETA SYSTEMS CO., LTD.EBZ2026-04-22
08809455602546Demi ProMETA SYSTEMS CO., LTD.EBZ2026-04-22
08809455602553Demi ProMETA SYSTEMS CO., LTD.EBZ2026-04-22
08809455602560Demi ProMETA SYSTEMS CO., LTD.EBZ2026-04-22
00348783015638Lumira™ LED Curing LightPREMIER DENTAL PRODUCTS COMPANYEBZ2026-04-22
08800017901640CybirdDXM CO., LTDEBZ2026-04-21
08809455602508Demi ProMETA SYSTEMS CO., LTD.EBZ2026-04-21
08809455602577Demi ProMETA SYSTEMS CO., LTD.EBZ2026-04-21
00348783015492Lumira™ LED Curing LightPREMIER DENTAL PRODUCTS COMPANYEBZ2026-04-14
00883205032997VALOULTRADENT PRODUCTS, INC.PEQ2025-08-20
00883205032997VALOULTRADENT PRODUCTS, INC.EAQ2025-08-20
00883205032980VALOULTRADENT PRODUCTS, INC.PEQ2025-03-11
00883205032980VALOULTRADENT PRODUCTS, INC.EAQ2025-03-11
07615208476217Bluephase EasyCureIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBZ2024-09-25
D6620708507352Patterson®PATTERSON DENTAL SUPPLY, INC.EBZ2024-05-08
D6620708540002Patterson®PATTERSON DENTAL SUPPLY, INC.EBZ2024-05-08
D6620708540182Patterson®PATTERSON DENTAL SUPPLY, INC.EBZ2024-05-08
07615208458787Bluephase PowerCureIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBZ2024-03-25
00883205034168VALOULTRADENT PRODUCTS, INC.PEQ2024-02-24
00883205034168VALOULTRADENT PRODUCTS, INC.EAQ2024-02-24
00883205034175VALOULTRADENT PRODUCTS, INC.PEQ2024-02-24
00883205034175VALOULTRADENT PRODUCTS, INC.EAQ2024-02-24
00883205034182VALOULTRADENT PRODUCTS, INC.PEQ2024-02-24
00883205034182VALOULTRADENT PRODUCTS, INC.EAQ2024-02-24