# K013277: Astralis 7, Model 557545

- Pathway: 510(k) (Traditional)
- Applicant: Ivoclar Vivadent, Inc.
- Decided: Oct 22, 2001 after 20 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.
26 later devices descend from it; 1 cites it directly.
0 of 27 devices 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.

## Most influential descendants
- K073033: Legacy Dental Implants (2007), 25 descendants of its own
- K090234: Spectra System Dental Implants 2008 (2009), 22 descendants of its own
- K130572: Interactive/ SWISHPLUS2 Implant System (2013), 10 descendants of its own
- K143011: 2014 InterActive/SwishActive System (2015), 8 descendants of its own
- K181359: InterActive SMARTBase Abutments (2018), 6 descendants of its own

## Indications for use
Astralis 7 is a hand held polymerization unit used to cure dental composites

Source page: https://510kreport.com/device/K013277
Methodology: https://510kreport.com/methodology