# K113739: Simplant Immediate Smile Dental Care System

- Pathway: 510(k) (Traditional)
- Applicant: Materialise Dental NV
- Decided: May 30, 2012 after 162 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). 11 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 15 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 2.
- K050393: The Guided Surgery Concept, Nobel Biocare AB (2005) Summary page 2.
- K093708: Telio Cad, Ivoclar Vivadent, Inc. (2010) Summary page 2.

## Most influential descendants
- K170849: SIMPLANT Guide (2017), 2 descendants of its own
- K193405: Simplant Digital Guide (2020), 0 descendants of its own
- K190059: CEREC Guides (2019), 0 descendants of its own

## Indications for use
The Sinilant Immediate Smile System is intended for use in treatment planning and placement of dental implants, in order to restore masticatory function.

Source page: https://510kreport.com/device/K113739
Methodology: https://510kreport.com/methodology