510(k) Report

Devices descending from K042178

38 later devices reach Orthodontic Ceramic Brackets through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082974Mystique MB Ceramic BracketsDentsply Interntional200823—
+1K060837IN-Ovation CDentsply International200620—
+1K052370CP Bracket SystemDentsply International20050—
+1K052245Accent and Exceed Series Orthodontic Ceramic BracketsLar Mfg., LLC20050—
+2K220689Vatech ClismileRayence Co., Ltd.20220—
+2K160957CDB Self Ligating Bracket 8FCdb Corporation20160—
+2K123092Ceramin Brackets ZTomy, Inc.20120—
+2K122753Empower ClearAmerican Orthodontics20121—
+2K123094Orthodontic Ceramic BracketsTomy, Inc.20127—
+2K111234Click-ITTp Orthodontics, Inc.20111—
+2K102803Clarity Advanced Ceramic Brackets3M Unitek Corporation201115—
+2K091702CDB Flip-Side-Clip BracketCdb Corporation20090—
+2K092030Elation MB Metal Reinforced Plastic BracketDentsply Interntional20094—
+2K090933Bernhard-Forster GMBH Orthodontic Ceramic BracketsForestadent Bernhard Forster GmbH20092—
+2K090454Allure MB Ceramic BracketsDentsply Interntional20095—
+2K081291Pre-Cemented Orthodontic Bracket System ExtensionDentsply Interntional20081—
+3K232011CleoAmerican Orthodontics20230—
+3K222847Ceramic Brackets OrthometricOrthometric - Industria E Comercio DE Produtos Medicos20230—
+3K180718Orthodontic Plastic Brackets and AccessoriesTomy, Inc.20180—
+3K1804043M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System3M Healthcare20180—
+3K172845Symetri ClearOrmco Corporation20180—
+3K163467C-Line Orthodontic Ceramic BracketBiocetec Co., Ltd.20172—
+3K160615Orthodontic Ceramic Brackets 1.1Tomy, Inc.20166—
+3K140807Composite Orthodontic BracketsOrtho Specialties20142—
+3K141104Truklear BracketAjw Technology Consultants, Inc.20140—
+3K131197Edgewise Ceramic Brackets, Roth Ceramic BracketsDental Morelli20130—
+3K120471Mach Brackets Bright BracketsWorld Bio Tech Co., Ltd.20120—
+3K093221Pre-Cemented Orthodontic Bracket System Extension IIDentsply Intl., Inc.20090—
+4K201940Braces on Demand BracketBraces on Demand, Inc.20200—
+4K180952Ceramic BracketMem Dental Technology Co., Ltd.20190—
+4K182193S-LineBiocetec Co., Ltd.20191—
+4K181271Signature Orthodontic SystemSignature Orthodontics20184—
+4K150830CompleClear Plastic Orthodontic Bracket and Wire ApplianceOracrew20160—
+5K231635A-Line AdvancedBiocetec Co., Ltd.20230—
+5K222764LightForce Orthodontic SystemLightforce Orthodontics20221—
+5K183542Signature Orthodontic SystemSignature Orthodontics20191—
+6K232827LightForce Orthodontic SystemLightforce Orthodontics20230—
+6K200148LightForce Orthodontic System (LFO System)Lightforce Orthodontics20200—