AccessGUDID - DEVICE: SmartLite® Pro (D0026444401)

GUDID

Device Identifier (DI) Information

Brand Name: SmartLite® Pro
Version or Model: 644440
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 644440
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D0026444401
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: SmartLite® Pro-Endo Resto Kit

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35775	Dental/surgical polymerization lamp	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBZ	ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Use product at room temperature.
Storage Environment Humidity: less than 74 Percent (%) Relative Humidity
Storage Environment Temperature: between -5 and 35 Degrees Celsius
Special Storage Condition, Specify: Do not use after expiration date.
Special Storage Condition, Specify: Protect from moisture.
Special Storage Condition, Specify: Store at relative humidity range <75% (non-condensing)

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Handpiece with cure tip, transillumination tip, batteries, charging base, accessories box, EndoActivator attachment with 25 small tips, 25 medium tips, 25 medium long tips, and 100 barrier sleeves

Device Record Status

Public Device Record Key: f537e050-b0c6-414e-af44-4fe4e122911e
Public Version Date: September 06, 2022
Public Version Number: 1
DI Record Publish Date: August 29, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

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

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