# K161118: SIMPLANT Online Case Review and SIMPLANT Editor

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Sirona
- Decided: Jul 28, 2016 after 99 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K924630 (1993). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110300: Simplant 2011, Materialise Dental NV (2011) Summary page 4.

## Indications for use
SIMPLANT Online Case Review and SIMPLANT Editor are indicated for use as medical front-end software that can be used by medically trained people for the purpose of visualizing gray value images. These are intended for use as pre-operative software programs for generating and reviewing plans for dental implant placement and surgical treatment.

Source page: https://510kreport.com/device/K161118
Methodology: https://510kreport.com/methodology