# K170849: SIMPLANT Guide

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Sirona
- Decided: Jun 15, 2017 after 85 days
- Product code: NDP (Accessories, Implant, Dental, Endosseous)
- Device class: 1
- Regulation: 21 CFR 872.3980
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K924630 (1993). 12 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K113739: Simplant Immediate Smile Dental Care System, Materialise Dental NV (2012) Summary page 4.

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

## Indications for use
The SIMPLANT® Guide is intended for use in assisting placement of dental implants.

Source page: https://510kreport.com/device/K170849
Methodology: https://510kreport.com/methodology