FDA.report

DCI Edge

Primary DI
00810021437255
Brand
DCI Edge
Company
DCI International, LLC
Model
LX4
Catalog number
LX4000
Device description
Cabinet Mount Series 4 Light, 120 Volt, White
Published
2024-05-13
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

Related Records

Contact Domains

Product Codes

CodeName
EAZLight, Operating, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
EAZLight, Operating, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810021437255PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810021437255008100214372558100214372550810021437255

GMDN Terms

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

Contacts

PhoneEmail
5035372445regulatory@dcionline.com

Regulatory Flags

DUNS number
032221423
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00810021439549DCI Edge42856W2026-03-23
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00810021439563DCI Edge42857W2026-03-23
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00810021439594DCI Edge52906G2026-03-23
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00810021439525DCI Parts4404R2026-03-20
00810021436791DCI Edge420432025-12-15
00810021437835DCI EdgePJT13852025-08-11
00810021436876DCI EdgeDS5051+2025-02-24
00810021436883DCI EdgeDS5550+2025-02-24
00810021436937DCI EdgeDS5551+2025-02-24
00810021436944DCI EdgeDO5650+2025-02-24
00810021437019DCI EdgeDO5550+2025-02-24
00810021437026DCI EdgeDO5050+2025-02-24
00810021437033DCI EdgeDO5150+2025-02-24

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