510(k) Report

Devices descending from K964852

15 later devices reach Radiacare Oral Wound Rinse through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063148Sock IT! Oral Pain GelMerlin Group Dba Mcmerlin Dental Company20078—
+1K042400Mucotrol Concentrated Oral Gel WaferBelcher Pharmaceuticals, Inc.200401
+1K024180Oramagicrx Oral Wound RinseMpm Medical., Inc.20037—
+1K991923Soothe-N-Seal Canker Sore ReliefClosure Medical Corp.19990—
+2K260120NaturaJel™ Oral Wound Care KitHCS Innovation, LLC20260—
+2K210211PuraStat-OM3-D Matrix, Inc.20214—
+2K193336Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound RinseSynedgen, Inc.20200—
+2K191987OrapeuticForward Science20190—
+2K062795Mugard Mucoadhesive Oral Wound RinseAccess Pharmaceuticals, Inc.20065—
+2K060340Oramagic Plus Oral Wound RinseMpm Medical., Inc.20060—
+3K213552PuraStat-RM3-D Matrix, Inc.20223—
+3K140558ProctigardAccess Pharmaceuticals, Inc.20144—
+4K261504PuraStat-RM3-D Matrix, Inc.20260—
+4K242634PuraStat3-D Matrix Europe SAS20252—
+5K253923PuraStat3-D Matrix Europe SAS20261—