FDA 510(k)

Simplant Digital Guide

K-Number: K193405 · 2020-09-02

Decision Date2020-09-02

Product CodeNDP

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Simplant Digital Guide is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Sirona. It received FDA 510(k) clearance on 2020-09-02 under 510(k) number K193405. The device is classified under product code NDP. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Simplant Digital Guide?

Simplant Digital Guide is a medical device that received FDA 510(k) clearance on 2020-09-02. The listed applicant is Dentsply Sirona. The 510(k) number is K193405.

When did Simplant Digital Guide receive FDA 510(k) clearance?

Simplant Digital Guide received FDA 510(k) clearance on 2020-09-02, under 510(k) number K193405.

Who is the listed applicant for Simplant Digital Guide?

The FDA 510(k) record lists Dentsply Sirona as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Simplant Digital Guide?

The FDA product code for Simplant Digital Guide is NDP.

Other records listing Dentsply Sirona as applicant

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.