510(k) Report

Devices descending from K962941

5 later devices reach Oolitt Tongue Cleaner, Regular Low Ripple/Special High Ripple/Low Ripple… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K992270Miraclebreath Tongue CleanerStellar Labs, Inc.19990—
+1K973175Tongue KleanSoftek Ent.19971—
+1K972644Breath-SO-Fresh Tongue CleanerIntl. Dental Design Specialists, Inc.19973—
+2K990344Oralgiene Tongue CleanerOralgiene USA, Inc.19990—
+2K983683Unik Tongue CleanerUnik Products, Inc.19991—