FDA.reportPublic FDA data

LUVIS-C700 Series

Primary DI
08800053045070
Brand
LUVIS-C700 Series
Company
DENTIS CO. ,LTD
Model
C700-H0S0A1
Device description
AC 100-240 V, 50-60 Hz, 30-45 VA
Published
2024-01-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EAZLight, Operating, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EAZLight, Operating, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800053045070PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800053045070088000530450708800053045070

GMDN Terms#

Term, Definition table
TermDefinition
LED dental light, line-poweredA mains electricity (AC-powered) device designed for use in dentistry to project an intense focused beam of light directly into or around the oral cavity of a patient via a light-emitting diode (LED) situated as the light head at the distal end of the device's light wand, to illuminate the site of a dental examination or procedure. The light head is connected to a light-intensity control unit and a transformer that supplies mains, stepped-down, low-voltage electricity (e.g., 12 volt), via a flexible cable; for oral cavity illumination, the light wand may be attached to a suction cannula, a dental chair headrest, or to a retractor hooked on the patient's lower jaw. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
694721181
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800313235241ScanTarget KITDSCTK2026-09-21
08800313235296ScanTargetDSCTL2026-09-21
08800313235302ScanTargetDSCTM2026-09-18
08800313235319ScanTargetDSCTS2026-09-18
08800313235326MU Gingival ScanBodyDSMUGSBF2026-09-18
08800313235425ScanTarget Bite CapDSCTBC42026-09-18
08800313235432ScanTarget Bite CapDSCTBC22026-09-18
08800313230017ChecQPEGDCQP272026-08-26
08800313230024ChecQPEGDCQP382026-08-26
08800313230031ChecQPEGDCQP502026-08-26
08800313230048ChecQPEGDCQP532026-08-26
08800313230055ChecQPEGDCQP542026-08-26
08800313230062ChecQPEGDCQP632026-08-26
08800313237429ChecQPEGDCQP322026-08-26
08800313237436ChecQPEGDCQP572026-08-26
08800313237443ChecQPEGDCQP482026-08-26
08800313237450ChecQPEGDCQP602026-08-26
08800313237467ChecQPEGDCQP012026-08-26
08800313237474ChecQPEGDCQP032026-08-26
08800313237481ChecQPEGDCQP282026-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841709125638MidmarkMIDMARK CORPORATIONEAZ2026-07-08
00840456221372JMUJMU DENTAL, INCEAZ2026-07-06
00840456221389JMUJMU DENTAL, INCEAZ2026-07-06
00840456221396JMUJMU DENTAL, INCEAZ2026-07-06
00840456221402JMUJMU DENTAL, INCEAZ2026-07-06
00840456221419JMUJMU DENTAL, INCEAZ2026-07-06
00840456221426JMUJMU DENTAL, INCEAZ2026-07-06
00841709121920MidmarkMIDMARK CORPORATIONEAZ2026-03-19
00841709122088MidmarkMIDMARK CORPORATIONEAZ2026-03-19
00841709122217MidmarkMIDMARK CORPORATIONEAZ2026-03-19
00841709121906MidmarkMIDMARK CORPORATIONEAZ2026-03-18
00841709121913MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709121937MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709121944MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709121951MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709121968MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709121975MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709121982MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709121999MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709122002MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709122019MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709122026MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709122033MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709122040MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709122057MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709122064MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709122071MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709122095MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709122101MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709122118MidmarkMIDMARK CORPORATIONEAZ2026-03-10