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FDA 510(k)

SomnoDent ALPHA

K-Number: K162306 · 2016-09-20

ApplicantSomnomed, Inc.
Decision Date2016-09-20
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SomnoDent ALPHA is a medical device manufactured by Somnomed, Inc.. It received FDA 510(k) clearance on 2016-09-20 under approval 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. It is manufactured by Somnomed, Inc.. The 510(k) number is K162306.

When was SomnoDent ALPHA approved by the FDA?

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

What company makes SomnoDent ALPHA?

SomnoDent ALPHA is manufactured by Somnomed, Inc..

What is the FDA product code for SomnoDent ALPHA?

The FDA product code for SomnoDent ALPHA is LRK.

Other Devices by Somnomed, Inc.

K183443SomnoDent Avant K233497Rest Assure System

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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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