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FDA 510(k)

SIMPLANT Online Case Review and SIMPLANT Editor

K-Number: K161118 · 2016-07-28

ApplicantDentsply Sirona
Decision Date2016-07-28
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SIMPLANT Online Case Review and SIMPLANT Editor is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Sirona. It received FDA 510(k) clearance on 2016-07-28 under 510(k) number K161118. 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 Online Case Review and SIMPLANT Editor?

SIMPLANT Online Case Review and SIMPLANT Editor is a medical device that received FDA 510(k) clearance on 2016-07-28. The listed applicant is Dentsply Sirona. The 510(k) number is K161118.

When did SIMPLANT Online Case Review and SIMPLANT Editor receive FDA 510(k) clearance?

SIMPLANT Online Case Review and SIMPLANT Editor received FDA 510(k) clearance on 2016-07-28, under 510(k) number K161118.

Who is the listed applicant for SIMPLANT Online Case Review and SIMPLANT Editor?

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 Online Case Review and SIMPLANT Editor?

The FDA product code for SIMPLANT Online Case Review and SIMPLANT Editor is LLZ.

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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.

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