# K193405: Simplant Digital Guide

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Sirona
- Decided: Sep 2, 2020 after 268 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: 7 generations back to K924630 (1993). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170849: SIMPLANT Guide, Dentsply Sirona (2017) Summary page 4.

## Indications for use
The Simplant® Digital Guide is a surgical guide intended for use in assisting in the placement of dental implants. The Simplant® Digital Guide is designed centrally by the Simplant® planning software and manufactured locally using Formlabs Dental SG resin, Loctite 4304 adhesive, and Formlabs equipment: Form 2 printer, FormWash and FormCure washing and post-curing equipment.

Source page: https://510kreport.com/device/K193405
Methodology: https://510kreport.com/methodology