FDA.report

SmartLite® Pro

Primary DI
D0026444401
Brand
SmartLite® Pro
Company
DENTSPLY INTERNATIONAL INC.
Model
644440
Catalog number
644440
Device description
SmartLite® Pro-Endo Resto Kit
Published
2022-08-29
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

Related Records

Product Codes

CodeName
EBZACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION

Product Code Classifications

CodeDeviceSpecialtyClass
EBZActivator, Ultraviolet, For PolymerizationDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D0026444401PrimaryHIBCC0

GMDN Terms

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.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Do not use after expiration date.
Special Storage Condition, Specify00Protect from moisture.
Special Storage Condition, Specify00Store at relative humidity range <75% (non-condensing)
Special Storage Condition, Specify00Use product at room temperature.
Storage Environment Humidity074 Percent (%) Relative Humidity
Storage Environment Temperature-5 Degrees Celsius35 Degrees Celsius

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
083235549
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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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