FDA.reportPublic FDA data

SmartLite® Pro Modular LED Curing Light

Primary DI
D0026444030
Brand
SmartLite® Pro Modular LED Curing Light
Company
DENTSPLY INTERNATIONAL INC.
Model
644403
Catalog number
644403
Device description
SmartLite® Pro Eye Protection Shields Refill
Published
2022-04-07
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBZACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBZActivator, Ultraviolet, For PolymerizationDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D0026444031PrimaryHIBCC0
D0026444030Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental/surgical polymerization lampA mains electricity (AC-powered), hand-held, device intended to be used to activate the polymerization of: 1) a dental resin-based material in the oral cavity; and/or 2) a surgical adhesive/sealant during an open-surgery procedure. It typically includes a light source [e.g., halogen, fluorescent, light-emitting diode (LED)] that emits light in the visible, or less frequently, ultraviolet spectrum, mounted in a handpiece that is typically attached to or used with a portable control unit or charging station.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry.
Storage Environment Temperature-5 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)532-2855MilfordDE-Customer-Service@dentsplysirona.com

Regulatory Flags#

DUNS number
083235549
Device count
5
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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D002624551001Polytrays62455100624551002022-07-07
D002624551011Polytrays62455101624551012022-07-07
D002624551021Polytrays62455102624551022022-07-07
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Primary DI, Brand, Company table
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08809455602546Demi ProMETA SYSTEMS CO., LTD.EBZ2026-04-22
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08809455602560Demi ProMETA SYSTEMS CO., LTD.EBZ2026-04-22
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