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FDA 510(k)

DENTIOIII series (DENTIOIII, DENTIOIII-S)

K-Number: K181297 · 2018-11-21

ApplicantHdx Will Corp.
Decision Date2018-11-21
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTIOIII series (DENTIOIII, DENTIOIII-S) is the device name listed in this FDA 510(k) record. The listed applicant is Hdx Will Corp.. It received FDA 510(k) clearance on 2018-11-21 under 510(k) number K181297. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DENTIOIII series (DENTIOIII, DENTIOIII-S)?

DENTIOIII series (DENTIOIII, DENTIOIII-S) is a medical device that received FDA 510(k) clearance on 2018-11-21. The listed applicant is Hdx Will Corp.. The 510(k) number is K181297.

When did DENTIOIII series (DENTIOIII, DENTIOIII-S) receive FDA 510(k) clearance?

DENTIOIII series (DENTIOIII, DENTIOIII-S) received FDA 510(k) clearance on 2018-11-21, under 510(k) number K181297.

Who is the listed applicant for DENTIOIII series (DENTIOIII, DENTIOIII-S)?

The FDA 510(k) record lists Hdx Will Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DENTIOIII series (DENTIOIII, DENTIOIII-S)?

The FDA product code for DENTIOIII series (DENTIOIII, DENTIOIII-S) is MUH.

Other records listing Hdx Will Corp. 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.

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