FDA.reportPublic FDA data

TPC

Primary DI
D861ALED60N0
Brand
TPC
Company
TPC ADVANCE TECHNOLOGY, INC.
Model
ALED60N
Catalog number
ALED60N
Device description
LED light cure
Published
2017-09-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
K001719000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K001719000Q-LUX PLASMA 100 LIGHT CURE UNITRolence Enterprise Co. , Ltd.2000-10-10EBZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D861ALED60N0PrimaryHIBCC0

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

Contacts#

Phone, Email table
PhoneEmail
6268104337sbeckley@tpcdental.com

Regulatory Flags#

DUNS number
968884275
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D861D650TPCD650ND6502018-08-22
D861A750LED0TPCa750leda750led2017-09-11
D861A750N0TPCA750NA750N2017-09-11
D861A800LED0TPCa800leda800led2017-09-11
D861A800N0TPCa800na800n2017-09-11
D861A850LED0TPCA850LEDA850LED2017-09-11
D861ALED25000TPCALED2500ALED25002017-09-11
D861ALED500TPCALED50ALED502017-09-11
D861ALED55BN0TPCALED55BNALED55BN2017-09-11
D861ALED55N0TPCALED55NALED55N2017-09-11
D861ALED70N0TPCALED70NALED70N2017-09-11
D861LED39N0TPCALED39NALED39N2017-09-04
D861PL1000TPCPL100PL1002017-09-11
D861PL1500TPCPL150PL1502017-09-11
D861PM250TPCPM25PM252017-09-11

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