# K073475: System Plus

- Pathway: 510(k) (Traditional)
- Applicant: Continental Dental Laboratory
- Decided: Mar 10, 2008 after 90 days
- Product code: ELW (Material, Impression)
- Device class: 2
- Regulation: 21 CFR 872.3660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K943574 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052090: Splash! Impression Material Device, Discus Dental, Inc. (2005) Summary page 2.

## Indications for use
System Plus is a vinyl polysiloxane dental impression material. It is ideal for one-step impressions to reproduce the structure of a patient's teeth and gums to produce crowns, bridges, inlays, partial and complete dentures, denture repairs, implants and other dental restorations prescribed by a dentist.

Source page: https://510kreport.com/device/K073475
Methodology: https://510kreport.com/methodology