FDA 510(k)

SIMPLANT Guide

K-Number: K170849 · 2017-06-15

Decision Date2017-06-15

Product CodeNDP

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

SIMPLANT 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 2017-06-15 under 510(k) number K170849. 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 Guide?

SIMPLANT Guide is a medical device that received FDA 510(k) clearance on 2017-06-15. The listed applicant is Dentsply Sirona. The 510(k) number is K170849.

When did SIMPLANT Guide receive FDA 510(k) clearance?

SIMPLANT Guide received FDA 510(k) clearance on 2017-06-15, under 510(k) number K170849.

Who is the listed applicant for SIMPLANT 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 Guide?

The FDA product code for SIMPLANT 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.