FDA.reportPublic FDA data

Clear Blue

Primary DI
00862314000301
Brand
Clear Blue
Company
JOHNSON-PROMIDENT
Model
Digi 2.0
Device description
LED curing light
Published
2017-08-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EBZActivator, Ultraviolet, For Polymerization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBZActivator, Ultraviolet, For PolymerizationDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172426000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172426000Clear Blue Digi LED Curing LightPromident, LLC2017-08-16EBZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00862314000301PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00862314000301008623140003018623140003010862314000301

GMDN Terms#

Term, Definition table
TermDefinition
Dental laboratory curing unitA mains electricity (AC-powered) device used in the dental laboratory for curing polymer-based materials. This can be achieved by heat, heat and pressure, light, or a combination of these. For a curing light used chairside see the appropriate GMDN code.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
965230188
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00862314000318Johnson-PromidentUI-S10S302017-09-06
00862314000325Johnson-PromidentUI-T10302017-09-06
00862314000332Johnson-PromidentUI-FS100252017-09-06
00862314000349Johnson-PromidentUI-P10252017-09-06
00862314000356Johnson-PromidentUI-T1000302017-09-06
00862314000363Johnson-PromidentUI-T3302017-09-06
00862314000370Johnson-PromidentUI-P10302017-09-06
00862314000387Johnson-PromidentUI-T10252017-09-06
00862314000394Johnson-PromidentUI-FS100302017-09-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00810126506191Luminary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEBZ2026-03-05
00810126506207Luminary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEBZ2026-03-05
J014660164550Starlight proKulzer GmbHEBZ2026-01-28
07615208476217Bluephase EasyCureIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBZ2024-09-25
00885797472557FlashMaxRmo, Inc.EBZ2024-08-23
00885797472564FlashMaxRmo, Inc.EBZ2024-08-23
00885797540911FlashMaxRmo, Inc.EBZ2024-08-23
00885797633545FlashMaxRmo, Inc.EBZ2024-08-23
D6620708507352Patterson®PATTERSON DENTAL SUPPLY, INC.EBZ2024-05-08
D6620708540002Patterson®PATTERSON DENTAL SUPPLY, INC.EBZ2024-05-08
D6620708540182Patterson®PATTERSON DENTAL SUPPLY, INC.EBZ2024-05-08
E22190021Caps WarmerVOCO GmbHEBZ2024-05-07
07615208458787Bluephase PowerCureIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBZ2024-03-25
07615208461206Bluephase G4IVOCLAR VIVADENT AKTIENGESELLSCHAFTEBZ2023-06-14
07630392901437Coltolux ComfortDent4You AGEBZ2023-02-01
07630392901444Coltolux ComfortDent4You AGEBZ2023-02-01