Device
3M™ Ortholux™ Luminous Curing Light Rechargeable Battery, 704-455, 1/Ea
Manufacturer
3M UNITEK CORPORATION
3M UNITEK CORPORATION
Model: 704-455
Catalog: 704-455
DI: 00652221149367
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-04-25
Current Version: 2026-05-04
Description
3M™ Ortholux™ Luminous Curing Light Rechargeable Battery, 704-455, 1/Ea
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
b4138a70-4afb-4e51-a47b-1ebbf0fa998b
Distribution Status:
In Commercial Distribution
DUNS Number:
008256356
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00652221149367
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 35775
Name: Dental/surgical polymerization lamp
Definition:
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.
FDA Product Codes
EBZ
ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION