FDA.reportPublic FDA data

Dental Light

Primary DI
08809985669859
Brand
Dental Light
Company
Megagen Implant Co. Ltd
Model
ML200
Catalog number
MC83-0003A
Published
2025-09-09
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
08809985669859PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809985669859088099856698598809985669859

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
687388178
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08806388221066AnyOne Internal FixtureIF5008IF5008C2015-06-25
08806388221073AnyOne Internal FixtureIF5008IF50082015-06-25
08806388221080AnyOne Internal FixtureIF5010IF5010C2015-06-29
08806388221097AnyOne Internal FixtureIF5010IF50102015-06-25
08806388221103AnyOne Internal FixtureIF5011IF5011C2015-06-25
08806388221110AnyOne Internal FixtureIF5011IF50112015-06-25
08806388221127AnyOne Internal FixtureIF5013IF5013C2015-06-25
08806388221134AnyOne Internal FixtureIF5013IF50132015-06-25
08806388221141AnyOne Internal FixtureIF5015IF5015C2015-06-25
08806388221158AnyOne Internal FixtureIF5015IF50152015-06-25
08806388221165AnyOne Internal FixtureIF5507DIF5507DC2015-06-25
08806388221172AnyOne Internal FixtureIF5508DIF5508DC2015-06-25
08806388221189AnyOne Internal FixtureIF5510DIF5510DC2015-06-25
08806388221196AnyOne Internal FixtureIF5511DIF5511DC2015-06-25
08806388221202AnyOne Internal FixtureIF5513DIF5513DC2015-06-25
08806388221219AnyOne Internal FixtureIF5515DIF5515DC2015-06-25
08806388221226AnyOne Internal FixtureIF6007IF6007C2015-06-25
08806388221233AnyOne Internal FixtureIF6007IF60072015-06-25
08806388221240AnyOne Internal FixtureIF6007SIF6007SC2015-06-25
08806388221257AnyOne Internal FixtureIF6007SIF6007S2015-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00841709122125MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709122187MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709122194MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709122200MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709122224MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709122231MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709122248MidmarkMIDMARK CORPORATIONEAZ2026-03-10