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EBF

Material, Tooth Shade, Resin

Product code
EBF
Device name
Material, Tooth Shade, Resin
Device class
Class 2
21 CFR
21 CFR 872.3690
Medical specialty
Dental
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
934

510(k) clearances, last 3 years (51)

Last three years. Most recent: 2026-07-01.

NumberDecision dateApplicantDevice nameSummary
K2622282026-07-01Ultradent Products, Inc.Transcend Bulk Fill Flowable CompositePDF
K2614852026-07-01Ivoclar Vivadent, Inc.Tetric plus Fill;Tetric plus FlowPDF
K2612462026-06-18GC America, Inc.SRGC-06PDF
K2610932026-06-02DiaDent Group InternationalDIAFILPDF
K2610712026-05-19DiaDent Group InternationalDIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOWPDF
K2608052026-05-11Vericom Co., Ltd.Dual CoreFDA
K2613572026-04-27Voco GmbHGrandio disc multicolorPDF
K2613562026-04-27Hangzhou SHINING3D Dental Technology CDura-CrownPDF
K2601522026-04-23Mmtech Projetos Tecnologicos ImportacaSmart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3PDF
K2606612026-04-15Sprintray, Inc.Midas RestoreFDA
K2530362026-04-06Aidite (Qinhuangdao) Technology Co., LLight-curing Coloring Materials (ALCM)PDF
K2607832026-03-11Kulzer, LLCVenus Diamond; Venus Diamond Flow; Venus Pearl; VenuPDF
K2542452026-03-03New Stetic, SAZAFIRA®PDF
K2601702026-01-21Hangzhou SHINING3D Dental Technology CLumiCeraPDF
K2524652025-12-05Mediclus Co., Ltd.Any-CorePDF
K2535132025-11-07Premier Dental Products CompanyMultiMatch Flow Chameleon AntiMicrobial CompositePDF
K2532362025-09-29Graphenano Dental S.L.G-BLOCKPDF
K2530532025-09-23Hangzhou SHINING3D Dental Technology CDura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1)PDF
K2519462025-08-29GC America, Inc.G aenial Universal Injectable IIPDF
K2512832025-06-06Mediclus Co., Ltd.Once-Fil FlowFDA
K2503172025-05-30Spident Co., Ltd.EsFlow PLUSPDF
K2515782025-05-27Shofu Dental CorporationBEAUTIFIL II—
K2507782025-05-23Dsi Dental Solutions, Ltd.Sil-FlowPDF
K2512392025-05-21Voco GmbHGrandioSO Unlimited—
K2507632025-05-12C.E.I.B.MedReonFDA
K2504972025-04-30Aidite (Qinhuangdao) Technology Co., LAdditive Manufacturing (Light Curing) Crown Bridge RPDF
K2508232025-04-14Mediclus Co., Ltd.Any-Com Flow—
K2502672025-03-14Kettenbach GmbH & Co. KGVisalys® Bulk Fill 1 x 4 g Syringe (15060); Visalys®PDF
K2427132025-02-07Mediclus Co., Ltd.Any-Com BulkPDF
K2425722024-12-20Rizhao Huge Biomaterials Company, Ltd.TopCEM-Try in Veneer Try-in GelPDF
K2437202024-12-18Deltamed GmbH3Delta UNlimited—
K2428162024-12-17Bisco, Inc.QuantiumPDF
K2332732024-11-27Prevest Denpro LimitedC&B Ceramic; C&B Permanent; C&B InterimFDA
K2329942024-10-18Dentscare LtdaVittra APS Unique FlowPDF
K2411312024-10-18Edelweiss Dentistry Products GmbHedelweiss CAD/CAM T-BLOCK; edelweiss CAD/CAM C-BLOCKPDF
K2420972024-10-15Den-Mat Holdings, LLCDenMat Bulk Fill CompositePDF
K2416732024-10-15Shenzhen Piocreat 3D Technology Co., LDenture Base Resin (PN-Denture (Red, White))PDF
K2420142024-10-08Meta Biomed Co., Ltd.Jet Flow BulkPDF
K2422772024-10-01Sprintray, Inc.Crown HTPDF
K2411472024-09-26Mediclus Co., Ltd.Any-ComPDF
K2406602024-09-17Kulzer, LLCSignum composite flow; Signum universal bond; SignumPDF
K2325592024-09-11Arum Dentistry Co., Ltd.C&B NFH HybridPDF
K2408232024-06-27Saremco Dental AGels extra low shrinkage® composite & els extra low sPDF
K2311422024-04-25Dws S.R.L.Temporis, Irix PlusPDF
K2401122024-03-15Sincera Technology (Changchun) Co., LtLight Cure CompositePDF
K2406942024-03-15Ultradent Products, Inc.FORMA Composite (Shade A3D)PDF
K2312632024-01-05Prevest Denpro LimitedFusion Core DC Flo; Fusion Flo; Fusion Flo SE; FusioPDF
K2330822023-12-22Rizhao Huge Biomaterials Company, Ltd.TopCEM Dual Cure Resin CementPDF
K2320502023-11-14Saremco Dental AGsaremco print BRIDGETECPDF
K2335962023-11-09Bego Bremer Goldschlägerei Wilh. HerbsVarseoSmile TriniQPDF
K2335022023-11-01Graphy, Inc.TERA HARZ IIPDF

42 summaries are archived here for direct download.

Official FDA classification page: EBF
Classification and pathway per current FDA publications. Data from openFDA (CC0).