FDA 510(k)

SomnoDent ALPHA

K-Number: K162306 · 2016-09-20

Decision Date2016-09-20

Product CodeLRK

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

SomnoDent ALPHA is the device name listed in this FDA 510(k) record. The listed applicant is Somnomed, Inc.. It received FDA 510(k) clearance on 2016-09-20 under 510(k) number K162306. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SomnoDent ALPHA?

SomnoDent ALPHA is a medical device that received FDA 510(k) clearance on 2016-09-20. The listed applicant is Somnomed, Inc.. The 510(k) number is K162306.

When did SomnoDent ALPHA receive FDA 510(k) clearance?

SomnoDent ALPHA received FDA 510(k) clearance on 2016-09-20, under 510(k) number K162306.

Who is the listed applicant for SomnoDent ALPHA?

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

What is the FDA product code for SomnoDent ALPHA?

The FDA product code for SomnoDent ALPHA is LRK.

Other records listing Somnomed, Inc. as applicant

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.

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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.