FDA.reportPublic FDA data

Battery_Drs Light Claver

Primary DI
08800025400210
Brand
Battery_Drs Light Claver
Company
GOOD DOCTORS CO., LTD.
Model
CL0200110
Device description
Accessories of Dr's Light clever (CL-DC20)
Published
2019-11-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K093751000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093751000CL-DC20, CL-DC21Good Doctors Co., Ltd.2010-02-24EBZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800025400210PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800025400210088000254002108800025400210

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.

Regulatory Flags#

DUNS number
688201036
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800025400692EZ SHOT SEIC-EZSE102026-01-15
08800025400159Dr.s cam VIC-DCCU742020-01-16
08800025400173EZ SHOT HD VIC-EZBU822020-01-16
08800025400456Dr's Light PRIMECL-DP402023-08-24
08800025400463Dr's Light CHOICECL-DP402023-08-24
08800025400524File Hook(1pcs)AC04012023-08-23
08800025400531Lip Hook(3pccs)AC04072023-08-23
08800025400135InspireIC-WHCD1002020-11-13
18800025400156Dr.s cam VIC-DCCU742020-01-16
18800025400170EZ SHOT HD VIC-EZBU822020-01-16
08800025400296Charger_DLDLT030M20012019-11-26
08800025400203Charger_Drs Light ClaverDC020M10012019-11-22
08800025400227Guide-cap_Drs Light ClaverCL02002102019-11-22
08800025400234Disposable cover_35x100_wideIC06002202019-11-22
08800025400241Disposable cover_60x200_wideIC06002302019-11-22
08800025400258Disposable cover_35x100_narrowIC06002102019-11-22
08800025400265Disposable cover_46x195_wide/100 pcsIC06002302019-11-22
08800025400289Disposable cover_60x280_narrowIC06002502019-11-22
08800025400012Whicam Story3_wirelessIC-WHT602019-10-30
08800025400029Whicam Story3_wiredIC-WHW612019-10-30

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
J014660573650Starlight 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