FDA UDI In Commercial Distribution 🇺🇸 United States

SmartLite® Pro Modular LED Curing Light

DI: D0029444001 · Model: 944400 · DENTSPLY INTERNATIONAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
SmartLite® Pro Modular LED Curing Light
Primary DI
D0029444001
Version / Model
944400
Company Name
DENTSPLY INTERNATIONAL INC.
Labeler DUNS
083235549
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-09-09
Public Version
1
Public Version Date
2025-09-17
Public Version Status
New
Public Device Record Key
8e2d780f-0411-41e0-ab7d-64a342d976b7

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
Yes
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
EBZ ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION

GMDN Terms

Code Name
35775 Dental/surgical polymerization lamp

Identifiers

Type ID
Primary D0029444001