FDA.reportPublic FDA data

Post Mount LED Light

Primary DI
00850043433200
Brand
Post Mount LED Light
Company
Engle Dental Systems, LLC
Model
P024710
Catalog number
P024710
Device description
MAIA post mount LED light for use with Engle 300 chair
Published
2022-12-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

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
00850043433200PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850043433200008500434332008500434332000850043433200

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.

Contacts#

Phone, Email table
PhoneEmail
(800)547-1906support@engledental.com

Regulatory Flags#

DUNS number
039794292
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
false
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
00850043433019Cabinet Side Mount Rear DeliveryP071450P0714502022-12-09
00850043433026Cabinet Asst Only Rear DeliveryP071460P0714602022-12-09
00850043433033AS1 Dr./Asst Rear DeliveryP070900P0709002022-12-09
00850043433040AS1 Wall Mnt Rear DeliveryP070902P0709022022-12-09
00850043433057Assistant Wall Mount ArmP070904P0709042022-12-09
00850043433064Rear DeliveryP071964P0719642022-12-09
00850043433071Silver Mobile CartP050300P0503002022-12-09
00850043433088Gold Mobile CartP050310P0503102022-12-09
00850043433095Platinum Mobile CartP050320P0503202022-12-09
00850043433101Asst Platinum CartP050330P0503302022-12-09
00850043433118Asst Silver CartP050340P0503402022-12-09
00850043433125Dr./Asst Tabletop CartP050135P0501352022-12-09
00850043433132Asst Tabletop CartP050145P0501452022-12-09
00850043433149Dr. Flip Top CartP050140P0501402022-12-09
00850043433156Hygiene Flip Top CartP050150P0501502022-12-09
00850043433170E300 Traverse Dental ChairP096540TP096540T2022-12-09
00850043433194Utility Center Mount LED LightP024720P0247202022-12-09
00850043433217Post Mount LED Light for Non-EngleP024715P0247152022-12-09
00850043433224Utility Center Mount LED Light for Non-EngleP024725P0247252022-12-09
00850043433231E300 360 Delivery SystemP070931P0709312022-12-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00841709121982MidmarkMIDMARK CORPORATIONEAZ2026-03-10