FDA.reportPublic FDA data

Dental composite resin kit

Definition
A collection of non-sterile substances intended for professional use during dental restoration and prosthesis installation/repair which includes composite resin material and additional materials to support restoration (e.g., etching solution, bonding agent, primer, prosthesis bonding agents, unfilled resin sealant/coating agents), and may include dedicated disposable devices associated with application; it does not include non-resin-based cements nor dental prosthesis. After application, this device cannot be reused.
GUDID devices
221
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
04035077001120Rocatec™ Soft3M Deutschland GmbH683402017-08-08
04035077001137Rocatec™ Plus3M Deutschland GmbH683502017-08-08
04035077004787Rocatec™ Plus3M Deutschland GmbH683762017-08-08
04035077004794Rocatec™ Soft3M Deutschland GmbH683772017-08-08
04035077008570CoJet™ Prep3M Deutschland GmbH686242017-08-08
04035077012829CoJet™ Sand3M Deutschland GmbH684112017-08-08
10304040051419Henry ScheinHENRY SCHEIN, INC.10080472020-12-28
D757A19520K1DUO-LINK SE Adh. Cementatn KitBISCO INC.A-19520K2017-06-12
D757A19730K1Duo-Link Universal Kit w/Ace Univ. Primer A&BBISCO INC.A-19730K2017-06-15
D757H81210K1AELITE Anterior Syringe KitBISCO INC.H-81210K2017-06-12
EKUR004513KA1PANAVIA™ Veneer LC KURARAY NORITAKE DENTAL INC.#4513-KA2021-11-05
J001702011005450CoJet™ Sand3M Deutschland GmbH684112016-09-24
J001702011075810Rocatec™ Soft3M Deutschland GmbH683402016-09-24
J001702011075990Rocatec™ Plus3M Deutschland GmbH683502016-09-24
J001702011357720Rocatec™ Plus3M Deutschland GmbH683762016-09-24
J001702011357800Rocatec™ Soft3M Deutschland GmbH683772016-09-24
J001702011423070CoJet™ Prep3M Deutschland GmbH686242016-09-24
MEVK11Envision Complete Bonding SystemCHAMELEON DENTAL PRODUCTS, INCEVK2018-11-08
MEVKM1 Envision Complete Bonding System (modified)CHAMELEON DENTAL PRODUCTS, INCEVKM2018-11-08
MEVKSM1MIRAGE ENVISION STARTER BONDING KIT-MODIFIEDCHAMELEON DENTAL PRODUCTS, INCEVKSM2019-02-21
D9560SILFLO5Sil-FlowD.S.I DENTAL SOLUTIONS LTDSILFLO52025-06-26
D161230010AxioComp NTAxiodent Inc.23001 Refill Pack Shade A12024-10-07
D161230030AxioFlowAxiodent Inc.23013 Combo Pack Shades A2 A3 B2 & B32024-10-07
D161230040AxioComp NTAxiodent Inc.23004 Intro Pack with AxioBond 72024-10-07
D161230080AxioComp NTAxiodent Inc.23008 Master Pack with AxioBond 7 AxioFlow AxioGlo2024-10-07
D161230090AxioComp NTAxiodent Inc.23009 Unit Dose Compules Shade A12024-10-07
D161230110AxioFlowAxiodent Inc.23011 Trial Pack Shade A12024-10-07
D161230120AxioFlowAxiodent Inc.23012 Intro Pack Shade A1 A2 A3 or A3.52024-10-07
D161230190AxioFlo SEAxiodent Inc.23019 Trial Pack Shades A1 A2 A3 A3.5 B1 or B22024-10-07
D161230200AxioFlo SEAxiodent Inc.23020 Intro Pack Pouch Shades A1 A2 A3 A3.5 B1 or 2024-10-07
D161230210AxioFlo SEAxiodent Inc.23021 Intro Pack Box Shades A1 A2 A3 A3.5 B1 or B22024-10-07
D161230220AxioCore DCAxiodent Inc.23022 Intro Pack Automix2024-10-07
D967200270Fusion Core DC Flo and Fusion Bond DCPREVEST DENPRO LIMITEDCombo Pack2025-02-10
D161230560AxioComp NTAxiodent Inc.23056 20 x 0.25g unit dose compules Shade A32024-11-12
D161230570AxioComp NTAxiodent Inc.23057 20 x 0.25g unit dose compules Shade A3.52024-11-12
D161230580AxioComp NTAxiodent Inc.23058 20 x 0.25g unit dose compules Shade A42024-11-12
D161230590AxioComp NTAxiodent Inc.23059 20 x 0.25g unit dose compules Shade B12024-11-12
D161230600AxioComp NTAxiodent Inc.23060 20 x 0.25g unit dose compules Shade B22024-11-12
D161230610AxioComp NTAxiodent Inc.23061 20 x 0.25g unit dose compules Shade B32024-11-12
D161230620AxioComp NTAxiodent Inc.23062 20 x 0.25g unit dose compules Shade C12024-11-12
D161230630AxioComp NTAxiodent Inc.23063 20 x 0.25g unit dose compules Shade C22024-11-12
D161230640AxioComp NTAxiodent Inc.23064 20 x 0.25g unit dose compules Shade C32024-11-12
D161230650AxioComp NTAxiodent Inc.23065 20 x 0.25g unit dose compules Shade D12024-11-12
D161230660AxioComp NTAxiodent Inc.23066 20 x 0.25g unit dose compules Shade D22024-11-12
D161230670AxioComp NTAxiodent Inc.23067 20 x 0.25g unit dose compules Shade D32024-11-12
D161230680AxioComp NTAxiodent Inc.23068 20 x 0.25g unit dose compules Shade Incisal2024-11-12
D161230690AxioComp NTAxiodent Inc.23069 20 x 0.25g unit dose compules Shade Opaque2024-11-12
D161230700AxioComp NTAxiodent Inc.23070 20 x 0.25g unit dose compules Shade OA12024-11-12
D161230710AxioComp NTAxiodent Inc.23071 20 x 0.25g unit dose compules Shade OA22024-11-12
D161230720AxioComp NTAxiodent Inc.23072 20 x 0.25g unit dose compules Shade OA32024-11-12
D161230730AxioComp NTAxiodent Inc.23073 20 x 0.25g unit dose compules Shade Extra Bl2024-11-12
D161230740AxioComp NTAxiodent Inc.23074 20 x 0.25g unit dose compules Shade Bleach2024-11-12
D161230750AxioComp NTAxiodent Inc.23075 20 x 0.25g unit dose compules Shade Gingival2024-11-12
D161230760AxioComp NTAxiodent Inc.23076 20 x 0.25g unit dose compules Shade Gingival2024-11-12
D161230770AxioComp NTAxiodent Inc.23077 20 x 0.25g unit dose compules Shade Gingival2024-11-12
D161230780AxioComp NTAxiodent Inc.23078 20 x 0.25g unit dose compules Shade Gingival2024-11-12
D161230790AxioFlowAxiodent Inc.23079 Trial Pack Shade A22024-11-12
D161230800AxioFlowAxiodent Inc.23080 Trial Pack Shade A32024-11-12
D161230810AxioFlowAxiodent Inc.23081 Trial Pack Shade A3.52024-11-12
D161230820AxioFlowAxiodent Inc.23082 Trial Pack Shade A42024-11-12
D161230830AxioFlowAxiodent Inc.23083 Trial Pack Shade B12024-11-12
D161230840AxioFlowAxiodent Inc.23084 Trial Pack Shade B22024-11-12
D161230850AxioFlowAxiodent Inc.23085 Trial Pack Shade B32024-11-12
D161230860AxioFlowAxiodent Inc.23086 Trial Pack Shade C12024-11-12
D161230870AxioFlowAxiodent Inc.23087 Trial Pack Shade C22024-11-12
D161230880AxioFlowAxiodent Inc.23088 Trial Pack Shade C32024-11-12
D161230890AxioFlowAxiodent Inc.23089 Trial Pack Shade OA12024-11-12
D161230900AxioFlowAxiodent Inc.23090 Trial Pack Shade OA22024-11-12
D161230910AxioFlowAxiodent Inc.23091 Trial Pack Shade OA32024-11-12
D161230920AxioFlowAxiodent Inc.23092 Trial Pack Shade OA3.52024-11-12
D161230930AxioFlowAxiodent Inc.23093 Trial Pack Shade G12024-11-12
D161230940AxioFlowAxiodent Inc.23094 Trial Pack Shade G22024-11-12
D161230950AxioFlowAxiodent Inc.23095 Trial Pack Shade G32024-11-12
D161230960AxioFlowAxiodent Inc.23096 Trial Pack Shade G42024-11-12
D161230970AxioFlowAxiodent Inc.23097 Trial Pack Shade Bleach2024-11-12
D161230980AxioFlowAxiodent Inc.23098 Trial Pack Shade Incisal2024-11-12
D161230990AxioFlowAxiodent Inc.23099 Trial Pack Shade Opaque2024-11-12
D161230240AxioGlassAxiodent Inc.23024 Trial Pack2024-11-11
D161230250AxioGlassAxiodent Inc.23025 1 x 3g syringe 10 applicator tips2024-11-11
D161230260AxioGlassAxiodent Inc.23026 Intro Pack2024-11-11