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FDA 510(k)

ASD Oral Appliances

K-Number: K163580 · 2017-06-08

ApplicantAmerican Sleep Dentistry
Decision Date2017-06-08
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ASD Oral Appliances is the device name listed in this FDA 510(k) record. The listed applicant is American Sleep Dentistry. It received FDA 510(k) clearance on 2017-06-08 under 510(k) number K163580. 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 ASD Oral Appliances?

ASD Oral Appliances is a medical device that received FDA 510(k) clearance on 2017-06-08. The listed applicant is American Sleep Dentistry. The 510(k) number is K163580.

When did ASD Oral Appliances receive FDA 510(k) clearance?

ASD Oral Appliances received FDA 510(k) clearance on 2017-06-08, under 510(k) number K163580.

Who is the listed applicant for ASD Oral Appliances?

The FDA 510(k) record lists American Sleep Dentistry as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ASD Oral Appliances?

The FDA product code for ASD Oral Appliances is LRK.

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.

K261912SnØreNegatØrDnB Innovations, LLCK261366VirtusSomnomed, Inc.K261251Snorbliss® Anti-Snoring DeviceEndeavor Commerce, LLCK261134Dormiva Anti-Snoring Mouth GuardKoncept Innovators, Inc.K252942ShaeferHShaeferh, LLCK253845Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)Ram.Shaw Pte. , Ltd.

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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