Material, Tooth Shade, Resin
Regulation 872.3690
19510(k)s in 12 months (937 all time)
2recalls in 12 months (71 all time)
71recalls that name a 510(k)
Top companies in EBF
| Company | 510(k)s | Recalls |
|---|---|---|
| Kerr Corp. | 9 | 43 |
| Voco GmbH | 45 | 1 |
| Sybron Dental Specialties | 28 | 7 |
| Bisco, Inc. | 30 | 0 |
| Pulpdent Corp. | 29 | 0 |
| Scientific Pharmaceuticals, Inc. | 29 | 0 |
| Dentsply Intl. | 28 | 0 |
| Ivoclar North America, Inc. | 28 | 0 |
| Shofu Dental Corp. | 27 | 0 |
| GC America, Inc. | 24 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 21, 2026 | K262982 | Core·it Dual Spident Co., Ltd., KR | EBF |
| Sep 10, 2026 | K262202 | Cerasmart Forte GC America, Inc. | EBF |
| Aug 31, 2026 | K261695 | Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF) Guilin Kevin Peter Technology Co., Ltd., CN | EBF |
| Jul 1, 2026 | K262228 | Transcend Bulk Fill Flowable Composite Ultradent Products, Inc. | EBF |
| Jul 1, 2026 | K261485 | Tetric plus Fill;Tetric plus Flow Ivoclar Vivadent, Inc. | EBF |
| Jun 18, 2026 | K261246 | SRGC-06 GC America, Inc. | EBF |
| Jun 2, 2026 | K261093 | DIAFIL DiaDent Group International, KR | EBF |
| May 19, 2026 | K261071 | DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g) DiaDent Group International, KR | EBF |
| May 11, 2026 | K260805 | Dual Core Vericom Co., Ltd., KR | EBF |
| Apr 27, 2026 | K261357 | Grandio disc multicolor Voco GmbH, DE | EBF |
| Apr 27, 2026 | K261356 | Dura-Crown Hangzhou SHINING3D Dental Technology Co., Ltd., CN | EBF |
| Apr 23, 2026 | K260152 | Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT) Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda., BR | EBF |
| Apr 15, 2026 | K260661 | Midas Restore Sprintray, Inc. | EBF |
| Apr 6, 2026 | K253036 | Light-curing Coloring Materials (ALCM) Aidite (Qinhuangdao) Technology Co., Ltd., CN | EBF |
| Mar 11, 2026 | K260783 | Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One Kulzer, LLC | EBF |
| Mar 3, 2026 | K254245 | ZAFIRA® New Stetic, SA, CO | EBF |
| Jan 21, 2026 | K260170 | LumiCera Hangzhou SHINING3D Dental Technology Co., Ltd., CN | EBF |
| Dec 5, 2025 | K252465 | Any-Core Mediclus Co., Ltd., KR | EBF |
| Nov 7, 2025 | K253513 | MultiMatch Flow Chameleon AntiMicrobial Composite Premier Dental Products Company | EBF |
| Sep 29, 2025 | K253236 | G-BLOCK Graphenano Dental S.L., ES | EBF |
| Sep 23, 2025 | K253053 | Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) Hangzhou SHINING3D Dental Technology Co., Ltd., CN | EBF |
| Aug 29, 2025 | K251946 | G aenial Universal Injectable II GC America, Inc. | EBF |
| Jun 6, 2025 | K251283 | Once-Fil Flow Mediclus Co., Ltd., KR | EBF |
| May 30, 2025 | K250317 | EsFlow PLUS Spident Co., Ltd., KR | EBF |
| May 27, 2025 | K251578 | BEAUTIFIL II Shofu Dental Corporation | EBF |
| May 23, 2025 | K250778 | Sil-Flow Dsi Dental Solutions, Ltd., IL | EBF |
| May 21, 2025 | K251239 | GrandioSO Unlimited Voco GmbH, DE | EBF |
| May 12, 2025 | K250763 | Reon C.E.I.B.Med, KR | EBF |
| Apr 30, 2025 | K250497 | Additive Manufacturing (Light Curing) Crown Bridge Resin Aidite (Qinhuangdao) Technology Co., Ltd., CN | EBF |
| Apr 14, 2025 | K250823 | Any-Com Flow Mediclus Co., Ltd., KR | EBF |
| Mar 14, 2025 | K250267 | Visalys® Bulk Fill 1 x 4 g Syringe (15060); Visalys® Bulk Fill 15 x 0.25 g Caps (15062); Visalys® Bulk Flow 1 x 2 g Syri Kettenbach GmbH & Co. KG, DE | EBF |
| Feb 7, 2025 | K242713 | Any-Com Bulk Mediclus Co., Ltd., KR | EBF |
| Dec 20, 2024 | K242572 | TopCEM-Try in Veneer Try-in Gel Rizhao Huge Biomaterials Company, Ltd., CN | EBF |
| Dec 18, 2024 | K243720 | 3Delta UNlimited Deltamed GmbH, DE | EBF |
| Dec 17, 2024 | K242816 | Quantium Bisco, Inc. | EBF |
| Nov 27, 2024 | K233273 | C&B Ceramic; C&B Permanent; C&B Interim Prevest Denpro Limited, IN | EBF |
| Oct 18, 2024 | K241131 | edelweiss CAD/CAM T-BLOCK; edelweiss CAD/CAM C-BLOCK; edelweiss CAD/CAM i-BLOCK; Ceramir CAD/CAM T-BLOCK; Ceramir CAD/CA Edelweiss Dentistry Products GmbH, AT | EBF |
| Oct 18, 2024 | K232994 | Vittra APS Unique Flow Dentscare Ltda, BR | EBF |
| Oct 15, 2024 | K242097 | DenMat Bulk Fill Composite Den-Mat Holdings, LLC | EBF |
| Oct 15, 2024 | K241673 | Denture Base Resin (PN-Denture (Red, White)) Shenzhen Piocreat 3D Technology Co., Ltd., CN | EBF |
| Oct 8, 2024 | K242014 | Jet Flow Bulk Meta Biomed Co., Ltd., KR | EBF |
| Oct 1, 2024 | K242277 | Crown HT Sprintray, Inc. | EBF |
| Sep 26, 2024 | K241147 | Any-Com Mediclus Co., Ltd., KR | EBF |
| Sep 17, 2024 | K240660 | Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum Kulzer, LLC | EBF |
| Sep 11, 2024 | K232559 | C&B NFH Hybrid Arum Dentistry Co., Ltd., KR | EBF |
| Jun 27, 2024 | K240823 | els extra low shrinkage® composite & els extra low shrinkage® flow Saremco Dental AG, CH | EBF |
| Apr 25, 2024 | K231142 | Temporis, Irix Plus Dws S.R.L., IT | EBF |
| Mar 15, 2024 | K240694 | FORMA Composite (Shade A3D) Ultradent Products, Inc. | EBF |
| Mar 15, 2024 | K240112 | Light Cure Composite Sincera Technology (Changchun) Co., Ltd., CN | EBF |
| Jan 5, 2024 | K231263 | Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT Prevest Denpro Limited, IN | EBF |
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