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FDA 510(k)

AIRWAYEASE MAS

K-Number: K090436 · 2010-04-16

ApplicantOrthoplant Dental Lab
Decision Date2010-04-16
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AIRWAYEASE MAS is the device name listed in this FDA 510(k) record. The listed applicant is Orthoplant Dental Lab. It received FDA 510(k) clearance on 2010-04-16 under 510(k) number K090436. 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 AIRWAYEASE MAS?

AIRWAYEASE MAS is a medical device that received FDA 510(k) clearance on 2010-04-16. The listed applicant is Orthoplant Dental Lab. The 510(k) number is K090436.

When did AIRWAYEASE MAS receive FDA 510(k) clearance?

AIRWAYEASE MAS received FDA 510(k) clearance on 2010-04-16, under 510(k) number K090436.

Who is the listed applicant for AIRWAYEASE MAS?

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

What is the FDA product code for AIRWAYEASE MAS?

The FDA product code for AIRWAYEASE MAS is LRK.

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Related Devices (Code: LRK)

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

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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