FDA.reportPublic FDA data

A-dec

Primary DI
08054320513216
Brand
A-dec
Company
F.A.R.O. FABBRICA APPARECCHIATURE RAZIONALI ODONTOIATRICHE SPA
Model
E72
Catalog number
28.2230.00
Device description
A dental operating light is intended to illuminate the oral structures and operating areas of dental patients during diagnostic and therapeutic treatment by licensed health care professionals.
Published
2026-11-02
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

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
08054320513216PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08054320513216080543205132168054320513216

Regulatory Flags#

DUNS number
428638779
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08054320513261A-decS7628.2226.002026-11-02
08054320511960FAROEVA5S20420012024-04-05
08054320511984FAROEVA5C13420012024-04-05
08054320511991FAROEVA5C14400012024-04-05
08054320512004FAROEVA5C14420012024-04-05
08054320512370FAROB7555U0010002024-04-05
08034028397110FAROEDI LED5001210252023-07-07
08034028398148FAROMAIA3220104252023-07-07
08034028398162FAROMAIA3200104002023-07-07
08034028398179FAROMAIA3220104002023-07-07
08034028398216FAROMAIA3250104002023-07-07
08034028398360FAROMAIA3221104252023-07-07
08034028398377FAROMAIA3250104252023-07-07
08034028399169FAROMAIA3240293002023-07-07
08054320511106FAROMAIA3210000002023-07-07
08054320511533FAROEVA5C13600002023-07-07
08054320511601FAROEVA5S20600002023-07-07
08054320511953FAROEVA5S20400012023-07-07
08054320511977FAROEDI LED5C13400012023-07-07
08054320512158FAROEDI LED5001210252023-07-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719965090020LED Operating LightCHUAN FU MEDICAL INSTRUMENT CO., LTD.EAZ2026-10-22
08033837933021CEFLACEFLA SOCIETA' COOPERATIVAEAZ2026-10-13
08033837933045CEFLACEFLA SOCIETA' COOPERATIVAEAZ2026-10-13
08033837938583CEFLACEFLA SOCIETA' COOPERATIVAEAZ2026-10-13
08033837938606CEFLACEFLA SOCIETA' COOPERATIVAEAZ2026-10-13
08033837938644CEFLACEFLA SOCIETA' COOPERATIVAEAZ2026-10-13
08033837938682CEFLACEFLA SOCIETA' COOPERATIVAEAZ2026-10-13
08033837938699CEFLACEFLA SOCIETA' COOPERATIVAEAZ2026-10-13
08033837938705CEFLACEFLA SOCIETA' COOPERATIVAEAZ2026-10-13
08033837938712CEFLACEFLA SOCIETA' COOPERATIVAEAZ2026-10-13
08033837938729CEFLACEFLA SOCIETA' COOPERATIVAEAZ2026-10-13
08033837938736CEFLACEFLA SOCIETA' COOPERATIVAEAZ2026-10-13
08033837938743CEFLACEFLA SOCIETA' COOPERATIVAEAZ2026-10-13
00841709125638MidmarkMIDMARK CORPORATIONEAZ2026-07-08
00840456221372JMUJMU DENTAL, INCEAZ2026-07-06
00840456221389JMUJMU DENTAL, INCEAZ2026-07-06
00840456221396JMUJMU DENTAL, INCEAZ2026-07-06
00840456221402JMUJMU DENTAL, INCEAZ2026-07-06
00840456221419JMUJMU DENTAL, INCEAZ2026-07-06
00840456221426JMUJMU DENTAL, INCEAZ2026-07-06
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