FDA.reportPublic FDA data

A-dec

Primary DI
10194665000158
Brand
A-dec
Company
A-DEC, INC.
Model
371L
Catalog number
371L
Device description
A-dec 371L LED Dental Light
Published
2022-11-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
10194665000158PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1019466500015810194665000158

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
009617473
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
10194665008857A-decS76S762026-05-07
10194665008444A-dec54.0924.0154.0924.012026-02-19
10194665008475A-dec54.1073.0054.1073.002026-02-19
10194665008482A-dec54.1073.0154.1073.012026-02-19
10194665008499A-dec54.1074.0054.1074.002026-02-19
10194665008505A-dec54.1074.0154.1074.012026-02-19
10194665008512A-dec54.1051.0054.1051.002026-02-19
10194665008529A-dec54.1052.0054.1052.002026-02-19
10194665008550A-dec54.1076.0054.1076.002026-02-19
10194665004460A-dec54.0865.0054.0865.002022-11-07
10194665008697A-dec3453452026-02-17
10194665008666A-decAMDUWLAMDUWL2025-09-30
10194665008383A-dec311xlc311xlc2025-09-18
10194665006587A-dec311FLT311FLT2025-05-19
10194665006594A-dec511FLT511FLT2025-05-19
10194665007935ActeonC202025-05-15
10194665008321A-decNo Version or Model Number54.1042.002025-05-15
10194665008345A-decNo Version or Model Number54.1043.002025-05-15
10194665007928A-dec 54.1041.0054.1041.002025-02-11
10194665007911A-dec346134612025-01-24

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