510(k) Report

Devices descending from K163029

2 later devices reach Hydris™ Oral Rinse through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190144MucoPEGSunbio, Inc.20190—
+1K181194SmartMouth DryMouth Oral RinseTriumph Pharmaceuticals, Inc.20190—