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 a medical device manufactured by American Sleep Dentistry. It received FDA 510(k) clearance on 2017-06-08 under approval 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. It is manufactured by American Sleep Dentistry. The 510(k) number is K163580.
When was ASD Oral Appliances approved by the FDA?
ASD Oral Appliances received FDA 510(k) clearance on 2017-06-08, under approval number K163580.
What company makes ASD Oral Appliances?
ASD Oral Appliances is manufactured by American Sleep Dentistry.
What is the FDA product code for ASD Oral Appliances?
The FDA product code for ASD Oral Appliances is LRK.
Related Devices (Code: LRK)
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.