FDA.reportPublic FDA data

Dental Operating Light

Primary DI
D104SAF30201
Brand
Dental Operating Light
Company
Safari Dentaire Inc
Model
SAF-302-01
Catalog number
SAF-302-01
Device description
A dental operating light, including the surgical headlight, is an AC-powered device intended to illuminate oral structures and operating areas.
Published
2023-10-02
Public version status
New
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
D104SAF30201PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Fixed examination/treatment room lightA fixed device intended to provide light to illuminate a site of patient examination and/or treatment. It typically consists of one or more light bulb(s) and, depending upon the design, reflectors or mirrors which focus and reflect the light. The device can be fixed to a ceiling, wall, or supported on a mobile mount. It can also be part of an operating light system consisting of more than one light head.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
245011531
Device count
1
Premarket exempt
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D104SAF4302Dentacenter Operative Dental UnitSAF-430-2SAF-430-22023-10-05
D104SAF1031Safari Dental ChairSAF-103-12023-10-02
D104SAF430Dentacenter Operative Dental UnitSAF-4302023-10-02
D104SAF4302XP0Dentacenter Operative Dental UnitSAF-430-2XPSAF-430-2XP2023-10-02
D104SAF4303Dentacenter Operative Dental UnitSAF-430-22023-10-02
D104SAF433XP0Dentacenter Operative Dental UnitSAF-430-2XP2023-10-02
D104SAF470Dentacenter Operative Dental UnitSAF-4702023-10-02
D104SAF500CART0Dentacenter Operative Dental UnitSAF-500-CARTSAF-500-CART2023-10-02
D104SAF500M2Dentacenter Operative Dental UnitSAF-500-M22023-10-02
D104SAF500M4Dentacenter Operative Dental UnitSAF-500-M42023-10-02
D104SAF531SERIES2Dentacenter Operative Dental UnitSAF-531-Series II2023-10-02
D104SAF60626Dentacenter Operative Dental UnitSAF-606-2.62023-10-02
D104SAF60646Dentacenter Operative Dental UnitSAF-606-4.62023-10-02

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