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FDA 510(k)

DENTAL 3D PLANNING SOFTWARE

K-Number: K113404 · 2011-12-06

ApplicantSymbyo Dental, LLC
Decision Date2011-12-06
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DENTAL 3D PLANNING SOFTWARE is the device name listed in this FDA 510(k) record. The listed applicant is Symbyo Dental, LLC. It received FDA 510(k) clearance on 2011-12-06 under 510(k) number K113404. 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 DENTAL 3D PLANNING SOFTWARE?

DENTAL 3D PLANNING SOFTWARE is a medical device that received FDA 510(k) clearance on 2011-12-06. The listed applicant is Symbyo Dental, LLC. The 510(k) number is K113404.

When did DENTAL 3D PLANNING SOFTWARE receive FDA 510(k) clearance?

DENTAL 3D PLANNING SOFTWARE received FDA 510(k) clearance on 2011-12-06, under 510(k) number K113404.

Who is the listed applicant for DENTAL 3D PLANNING SOFTWARE?

The FDA 510(k) record lists Symbyo Dental, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DENTAL 3D PLANNING SOFTWARE?

The FDA product code for DENTAL 3D PLANNING SOFTWARE is LLZ.

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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.

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