FDA.reportPublic FDA data

A-dec

Primary DI
08054320513261
Brand
A-dec
Company
F.A.R.O. FABBRICA APPARECCHIATURE RAZIONALI ODONTOIATRICHE SPA
Model
S76
Catalog number
28.2226.00
Device description
A dental surgical light is intended to illuminate the oral structures and operating areas of dental patients during diagnostic and therapeutic treatment by licensed health care professionals. The light can provide two light spots: a) dental according to ISO 9680, 1 Surgical according to IEC 60601-2-41.
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
FTDLamp, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTDLamp, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08054320513261PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08054320513261080543205132618054320513261

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
08054320513216A-decE7228.2230.002026-11-02
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
10850009233049BihlerMedBihlerMed, L.L.C.FTD2026-07-24
10850009233056BihlerMedBihlerMed, L.L.C.FTD2026-07-24
10194665008857A-decA-DEC, INC.FTD2026-05-07
10850009233032BihlerMedBihlerMed, L.L.C.FTD2026-01-12
04048675754947PolarisDrägerwerk AG & Co. KGaAFTD2025-11-05
03700712434526Maquet PowerLED IIMAQUET SASFTD2025-09-03
03700712435851Maquet PowerLED IIMAQUET SASFTD2025-09-03
03700712436063Maquet PowerLED IIMAQUET SASFTD2025-09-03
03700712436087Maquet PowerLED IIMAQUET SASFTD2025-09-03
00850036790020AliteRevelle Aesthetics, Inc.FTD2025-09-01
00816744027230Myriad-LXNICO CORPORATIONFTD2025-08-11
00860013851576Nova 3QED, INC.FTD2025-05-22
00860013851507BeamerQED, INC.FTD2025-05-21
00860013851514Nova 300QED, INC.FTD2025-05-21
08800053093767S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093774S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093781S300 Series DENTIS CO. ,LTDFTD2025-02-19
08800053093798S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093804S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093828S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093835S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093842S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093859S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093866S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093873S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093880S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093897S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093903S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093910S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093927S300 SeriesDENTIS CO. ,LTDFTD2025-02-19