# K972355: 3M Aurora System

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company
- Decided: Aug 29, 1997 after 65 days
- Product code: EBZ (Activator, Ultraviolet, For Polymerization)
- Device class: 2
- Regulation: 21 CFR 872.6070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The 3M™ Aurora System is indicated to activate a photochemical polymerization reaction in light cure dental materials.

Source page: https://510kreport.com/device/K972355
Methodology: https://510kreport.com/methodology