FDA 510(k)

SIMPLANT 18

K-Number: K172239 · 2018-04-04

Decision Date2018-04-04

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

SIMPLANT 18 is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Sirona. It received FDA 510(k) clearance on 2018-04-04 under 510(k) number K172239. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIMPLANT 18?

SIMPLANT 18 is a medical device that received FDA 510(k) clearance on 2018-04-04. The listed applicant is Dentsply Sirona. The 510(k) number is K172239.

When did SIMPLANT 18 receive FDA 510(k) clearance?

SIMPLANT 18 received FDA 510(k) clearance on 2018-04-04, under 510(k) number K172239.

Who is the listed applicant for SIMPLANT 18?

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 18?

The FDA product code for SIMPLANT 18 is LLZ.

Other records listing Dentsply Sirona as applicant

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Official Source

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