Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
EBF — Predicate Candidate Screening
934 FDA 510(k) clearances under this product code; the 50 most recent screened below.
69 daysmedian FDA review time
176 days90th percentile
934clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261485 | Tetric plus Fill;Tetric plus Flow | Ivoclar Vivadent, Inc. | 2026-07-01 | 57 | 0 |
| K262228 | Transcend Bulk Fill Flowable Composite | Ultradent Products, Inc. | 2026-07-01 | 1 | 0 |
| K261246 | SRGC-06 | GC America, Inc. | 2026-06-18 | 63 | 0 |
| K261093 | DIAFIL | DiaDent Group International | 2026-06-02 | 61 | 0 |
| K261071 | DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill | DiaDent Group International | 2026-05-19 | 48 | 0 |
| K260805 | Dual Core | Vericom Co., Ltd. | 2026-05-11 | 60 | 0 |
| K261357 | Grandio disc multicolor | Voco GmbH | 2026-04-27 | 3 | 0 |
| K261356 | Dura-Crown | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2026-04-27 | 3 | 0 |
| K260152 | Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1 | Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda. | 2026-04-23 | 93 | 0 |
| K260661 | Midas Restore | Sprintray, Inc. | 2026-04-15 | 44 | 0 |
| K253036 | Light-curing Coloring Materials (ALCM) | Aidite (Qinhuangdao) Technology Co., Ltd. | 2026-04-06 | 196 | 0 |
| K260783 | Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk F | Kulzer, LLC | 2026-03-11 | 1 | 0 |
| K254245 | ZAFIRA® | New Stetic, SA | 2026-03-03 | 64 | 0 |
| K260170 | LumiCera | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2026-01-21 | 1 | 0 |
| K252465 | Any-Core | Mediclus Co., Ltd. | 2025-12-05 | 121 | 0 |
| K253513 | MultiMatch Flow Chameleon AntiMicrobial Composite | Premier Dental Products Company | 2025-11-07 | 1 | 0 |
| K253236 | G-BLOCK | Graphenano Dental S.L. | 2025-09-29 | 0 | 0 |
| K253053 | Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2025-09-23 | 1 | 0 |
| K251946 | G aenial Universal Injectable II | GC America, Inc. | 2025-08-29 | 65 | 0 |
| K251283 | Once-Fil Flow | Mediclus Co., Ltd. | 2025-06-06 | 42 | 0 |
| K250317 | EsFlow PLUS | Spident Co., Ltd. | 2025-05-30 | 115 | 0 |
| K251578 | BEAUTIFIL II | Shofu Dental Corporation | 2025-05-27 | 5 | 0 |
| K250778 | Sil-Flow | Dsi Dental Solutions, Ltd. | 2025-05-23 | 70 | 0 |
| K251239 | GrandioSO Unlimited | Voco GmbH | 2025-05-21 | 29 | 0 |
| K250763 | Reon | C.E.I.B.Med | 2025-05-12 | 60 | 0 |
| K250497 | Additive Manufacturing (Light Curing) Crown Bridge Resin | Aidite (Qinhuangdao) Technology Co., Ltd. | 2025-04-30 | 69 | 0 |
| K250823 | Any-Com Flow | Mediclus Co., Ltd. | 2025-04-14 | 27 | 0 |
| K250267 | Visalys® Bulk Fill 1 x 4 g Syringe (15060); Visalys® Bulk Fi | Kettenbach GmbH & Co. KG | 2025-03-14 | 43 | 0 |
| K242713 | Any-Com Bulk | Mediclus Co., Ltd. | 2025-02-07 | 151 | 0 |
| K242572 | TopCEM-Try in Veneer Try-in Gel | Rizhao Huge Biomaterials Company, Ltd. | 2024-12-20 | 113 | 0 |
| K243720 | 3Delta UNlimited | Deltamed GmbH | 2024-12-18 | 15 | 0 |
| K242816 | Quantium | Bisco, Inc. | 2024-12-17 | 90 | 0 |
| K233273 | C&B Ceramic; C&B Permanent; C&B Interim | Prevest Denpro Limited | 2024-11-27 | 425 | 0 |
| K241131 | edelweiss CAD/CAM T-BLOCK; edelweiss CAD/CAM C-BLOCK; edelwe | Edelweiss Dentistry Products GmbH | 2024-10-18 | 177 | 0 |
| K232994 | Vittra APS Unique Flow | Dentscare Ltda | 2024-10-18 | 392 | 0 |
| K242097 | DenMat Bulk Fill Composite | Den-Mat Holdings, LLC | 2024-10-15 | 89 | 0 |
| K241673 | Denture Base Resin (PN-Denture (Red, White)) | Shenzhen Piocreat 3D Technology Co., Ltd. | 2024-10-15 | 126 | 0 |
| K242014 | Jet Flow Bulk | Meta Biomed Co., Ltd. | 2024-10-08 | 90 | 0 |
| K242277 | Crown HT | Sprintray, Inc. | 2024-10-01 | 61 | 0 |
| K241147 | Any-Com | Mediclus Co., Ltd. | 2024-09-26 | 154 | 0 |
| K240660 | Signum composite flow; Signum universal bond; Signum metal b | Kulzer, LLC | 2024-09-17 | 193 | 0 |
| K232559 | C&B NFH Hybrid | Arum Dentistry Co., Ltd. | 2024-09-11 | 385 | 0 |
| K240823 | els extra low shrinkage® composite & els extra low shrinkage | Saremco Dental AG | 2024-06-27 | 93 | 0 |
| K231142 | Temporis, Irix Plus | Dws S.R.L. | 2024-04-25 | 370 | 0 |
| K240112 | Light Cure Composite | Sincera Technology (Changchun) Co., Ltd. | 2024-03-15 | 59 | 0 |
| K240694 | FORMA Composite (Shade A3D) | Ultradent Products, Inc. | 2024-03-15 | 1 | 0 |
| K231263 | Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal | Prevest Denpro Limited | 2024-01-05 | 248 | 0 |
| K233082 | TopCEM Dual Cure Resin Cement | Rizhao Huge Biomaterials Company, Ltd. | 2023-12-22 | 87 | 0 |
| K232050 | saremco print BRIDGETEC | Saremco Dental AG | 2023-11-14 | 127 | 0 |
| K233596 | VarseoSmile TriniQ | Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG | 2023-11-09 | 1 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda