FDA.report

A-dec

Primary DI
10194665000295
Brand
A-dec
Company
A-DEC, INC.
Model
578LA
Catalog number
578L
Device description
A-dec 578L LED Dental Light, Simulator Mt
Published
2022-11-08
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

Product Codes

CodeName
EAZLight, Operating, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
EAZLight, Operating, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10194665000295PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1019466500029510194665000295

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

Regulatory Flags

DUNS number
009617473
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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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