510(k) Report

Devices descending from K130504

2 later devices reach Asa Oral Appliances through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163580ASD Oral AppliancesAmerican Sleep Dentistry20171—
+2K190353Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTracResidential Home Sleep Services20200—