FDA.reportPublic FDA data

Drs Light Claver

Primary DI
18800025400088
Brand
Drs Light Claver
Company
GOOD DOCTORS CO., LTD.
Model
CL-DC20
Device description
ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION
Published
2019-10-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
18800025400088PackageGS11In Commercial Distribution
08800025400081PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1880002540008818800025400088
08800025400081088000254000818800025400081

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
688201036
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
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
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
08800025400210Battery_Drs Light ClaverCL02001102019-11-22
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

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