FDA.reportPublic FDA data

Dental composite resin

Definition
A non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.
GUDID devices
12,021
Last updated
2026-11-01 02:55:42

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00841396116285NX3Kerr Corporation336422016-08-01
EDMG2208011Ecosite ElementsDMG Chemisch-Pharmazeutische Fabrik GmbH2208012019-09-06
EDMG2208021Ecosite ElementsDMG Chemisch-Pharmazeutische Fabrik GmbH2208022019-09-06
EDMG2208031Ecosite ElementsDMG Chemisch-Pharmazeutische Fabrik GmbH2208032019-09-06
EDMG2208051Ecosite ElementsDMG Chemisch-Pharmazeutische Fabrik GmbH2208052019-09-06
EDMG2208061Ecosite ElementsDMG Chemisch-Pharmazeutische Fabrik GmbH2208062019-09-06
00814978021185Build-It FRKerr CorporationN32AA2016-08-01
00814978021192Build-It FRKerr CorporationN32AB2016-08-01
00814978021208Build-It FRKerr CorporationN32AC2016-08-01
00814978021215Build-It FRKerr CorporationN32AD2016-08-01
00814978021222Build-It FRKerr CorporationN32AE2016-08-01
00814978021321Build-It FRKerr CorporationN32FS2016-08-01
00814978021338Build-It FRKerr CorporationN32FSA2016-08-01
00814978021345Build-It FRKerr CorporationN32FSB2016-08-01
00814978021352Build-It FRKerr CorporationN32FSC2016-08-01
00814978021369Build-It FRKerr CorporationN32FSD2016-08-01
00814978021437Cement-It Universal C&BKerr CorporationN33A2016-08-01
00814978021444Cement-It Universal C&BKerr CorporationN33AB2016-08-01
00814978021451Cement-It Universal C&BKerr CorporationN33AC2016-08-01
00814978022588BreezeKerr CorporationN97E2016-08-01
00814978023240Build-It FRKerr CorporationN32F2016-08-01
00883205104205Composite Wetting ResinULTRADENT PRODUCTS, INC.30592016-09-22
10814978021267Build-It FRKerr CorporationN32FA2016-08-01
10814978021281Build-It FRKerr CorporationN32FB2016-08-01
10814978021298Build-It FRKerr CorporationN32FC2016-08-01
10814978021304Build-It FRKerr CorporationN32FD2016-08-01
10814978021311Build-It FRKerr CorporationN32FE2016-08-01
10814978023230Build-It FRKerr CorporationN322016-08-01
07615208477825Tetric plus FlowIVOCLAR VIVADENT AKTIENGESELLSCHAFT762403WW2026-10-19
07615208477832Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFT762404WW2026-10-19
00810111543644QuantiumBISCO INC.H-102A2PS2026-10-12
08806383540995DIAFILDiaDent Group InternationalA3 Refill Package2026-10-07
08806383541008DIAFILDiaDent Group InternationalA3.5 Refill Package2026-10-07
08806383541015DIAFILDiaDent Group InternationalA4 Refill Package2026-10-07
08806383541022DIAFILDiaDent Group InternationalB1 Refill Package2026-10-07
08806383541039DIAFILDiaDent Group InternationalB2 Refill Package2026-10-07
08806383541046DIAFILDiaDent Group InternationalB3 Refill Package2026-10-07
08806383541053DIAFILDiaDent Group InternationalC2 Refill Package2026-10-07
08806383541060DIAFILDiaDent Group InternationalC3 Refill Package2026-10-07
08806383541091DIAFILDiaDent Group InternationalCL Refill Package2026-10-07
08806383541107DIAFILDiaDent Group InternationalB4 Refill Package2026-10-07
08806383541114DIAFILDiaDent Group InternationalC1 Refill Package2026-10-07
08806383541121DIAFILDiaDent Group InternationalC4 Refill Package2026-10-07
08806383541138DIAFILDiaDent Group InternationalD1 Refill Package2026-10-07
08806383541145DIAFILDiaDent Group InternationalD2 Refill Package2026-10-07
08806383541152DIAFILDiaDent Group InternationalD3 Refill Package2026-10-07
08806383541169DIAFILDiaDent Group InternationalD4 Refill Package2026-10-07
08806383541176DIAFILDiaDent Group InternationalCapsule Type A12026-10-07
08806383541183DIAFILDiaDent Group InternationalCapsule Type A22026-10-07
08806383541190DIAFILDiaDent Group InternationalCapsule Type A32026-10-07
08806383541206DIAFILDiaDent Group InternationalCapsule Type A3.52026-10-07
08806383541213DIAFILDiaDent Group InternationalCapsule Type A42026-10-07
08806383541220DIAFILDiaDent Group InternationalCapsule Type B12026-10-07
08806383541237DIAFILDiaDent Group InternationalCapsule Type B22026-10-07
08806383541244DIAFILDiaDent Group InternationalCapsule Type B32026-10-07
08806383541251DIAFILDiaDent Group InternationalCapsule Type C22026-10-07
08806383541268DIAFILDiaDent Group InternationalCapsule Type C32026-10-07
08806383541299DIAFILDiaDent Group InternationalCapsule Type CL2026-10-07
08806383541305DIAFILDiaDent Group InternationalCapsule Type B42026-10-07
08806383541312DIAFILDiaDent Group InternationalCapsule Type C12026-10-07
08806383541329DIAFILDiaDent Group InternationalCapsule Type C42026-10-07
08806383541336DIAFILDiaDent Group InternationalCapsule Type D12026-10-07
08806383541343DIAFILDiaDent Group InternationalCapsule Type D22026-10-07
08806383541350DIAFILDiaDent Group InternationalCapsule Type D32026-10-07
08806383541367DIAFILDiaDent Group InternationalCapsule Type D42026-10-07
08806383541374DIAFILDiaDent Group InternationalA1_Intro Kit2026-10-07
08806383541381DIAFILDiaDent Group InternationalA2_Intro Kit2026-10-07
08806383541398DIAFILDiaDent Group InternationalA3_Intro Kit2026-10-07
08806383541404DIAFILDiaDent Group InternationalA3.5_Intro Kit2026-10-07
08806383541411DIAFILDiaDent Group InternationalA4_Intro Kit2026-10-07
08806383541428DIAFILDiaDent Group InternationalB1_Intro Kit2026-10-07
08806383541435DIAFILDiaDent Group InternationalB2_Intro Kit2026-10-07
08806383541442DIAFILDiaDent Group InternationalB3_Intro Kit2026-10-07
08806383541459DIAFILDiaDent Group InternationalC2_Intro Kit2026-10-07
08806383541466DIAFILDiaDent Group InternationalC3_Intro Kit2026-10-07
08806383541497DIAFILDiaDent Group InternationalCL_Intro Kit2026-10-07
08806383541503DIAFILDiaDent Group InternationalB4_Intro Kit2026-10-07
08806383541510DIAFILDiaDent Group InternationalC1_Intro Kit2026-10-07
08806383541527DIAFILDiaDent Group InternationalC4_Intro Kit2026-10-07
08806383541534DIAFILDiaDent Group InternationalD1_Intro Kit2026-10-07