510(k) Report

Devices descending from K053260

14 later devices reach Ossix -Plus through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153549Ossix VolumaxDatum Dental, Ltd.20160—
+1K160281Ossix PlusDatum Dental, Ltd.20161—
+1K123697Matricel Dental Barrier MembraneMatricel GmbH20140—
+1K132325Guidor Bioresorbable Matrix BarrierSunstar Americas, Inc.20130—
+1K103087Covamax Resorbable Collagen MembraneBiom'Up Sas201101
+1K110600Collagen Dental Mambrane - Porcine Type I CollagenCollagen Matrix, Inc.20110—
+1K101453Vitala Natural Resorbable Collagen MembraneObi Biologics, Inc.20114—
+1K102307Genoss Collagen Membrane Model GCM1020, GCM3040 Total 6 ModelsGenoss Co., Ltd.20110—
+1K071555Fortagen Oral MembraneOrganogenesis, Inc.20071—
+2K212509OSSIX BreezeDatum Dental, Ltd.20220—
+2K141177Vitala Porcine Derived Collagen MembraneOsteogenics Biomedical, Inc. (Formerly Obi Biologi20153—
+3K173562Straumann Jason MembraneInstitut Straumann AG20182—
+4K242817Jason membraneBotiss Biomaterials GmbH20250—
+4K223912InterCollagen® GuideSigmagraft, Inc.20230—