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FDA 510(k)

Dentti System

K-Number: K151965 · 2016-03-11

ApplicantMartz, Inc.
Decision Date2016-03-11
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dentti System is the device name listed in this FDA 510(k) record. The listed applicant is Martz, Inc.. It received FDA 510(k) clearance on 2016-03-11 under 510(k) number K151965. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dentti System?

Dentti System is a medical device that received FDA 510(k) clearance on 2016-03-11. The listed applicant is Martz, Inc.. The 510(k) number is K151965.

When did Dentti System receive FDA 510(k) clearance?

Dentti System received FDA 510(k) clearance on 2016-03-11, under 510(k) number K151965.

Who is the listed applicant for Dentti System?

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

What is the FDA product code for Dentti System?

The FDA product code for Dentti System is NXC.

Related Devices (Code: NXC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260527FACE4D AlignerAvinent Implant System S.L.U.K260788Smylio AlignersSmylio, Inc.K260722SureSmile Aligner (ASSY500020)Dentsply Sirona, Inc.K253282ZSmile SystemDror Orthodesign , Ltd.K251454Clear Aligner (SCF-3348)Beame Medical Technology (Shenzhen) LimitedK250739Primeprint Direct AlignerDreve Dentamid GmbH

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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