FDA.reportPublic FDA data

DCI Edge

Primary DI
00810021437125
Brand
DCI Edge
Company
DCI International, LLC
Model
LS5
Catalog number
LS5550
Device description
System Mount Series 5 Light, 120 Volt, Gray
Published
2024-05-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
00810021437125PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810021437125008100214371258100214371250810021437125

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

Contacts#

Phone, Email table
PhoneEmail
5035372445regulatory@dcionline.com

Regulatory Flags#

DUNS number
032221423
Device count
1
Premarket exempt
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810021439747DCI Edge423492026-04-14
00810021439754DCI Edge423502026-04-14
00810021439761DCI Edge423512026-04-14
10810021435210DCI EdgePJT6082026-04-13
10810021435227DCI EdgePJT6092026-04-13
00810021439440DCI EdgePJT608-22026-04-13
00810021439457DCI EdgePJT6582026-04-13
00810021439464DCI EdgePJT6592026-04-13
00810021439471DCI EdgePJT6602026-04-13
00810021439488DCI EdgePJT6612026-04-13
10810021435111DCI EdgePJT5982026-04-10
10810021435128DCI EdgePJT5992026-04-10
10810021435135DCI EdgePJT6002026-04-10
10810021435142DCI EdgePJT6012026-04-10
10810021435159DCI EdgePJT6022026-04-10
10810021435166DCI EdgePJT6032026-04-10
10810021435173DCI EdgePJT6042026-04-10
10810021435180DCI EdgePJT6052026-04-10
10810021435197DCI EdgePJT6062026-04-10
10810021435203DCI EdgePJT6072026-04-10

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