FDA Product Code
FDA Product Code EBF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.3690
510(k) Clearances — 937 records · page 1 of 10
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262982 | Core·it Dual | Spident Co., Ltd. | 2026-09-21 | Special | PDF ↗ |
| K262202 | Cerasmart Forte | GC America, Inc. | 2026-09-10 | Traditional | PDF ↗ |
| K261695 | Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF) | Guilin Kevin Peter Technology Co., Ltd. | 2026-08-31 | Traditional | PDF ↗ |
| K262228 | Transcend Bulk Fill Flowable Composite | Ultradent Products, Inc. | 2026-07-01 | Traditional | PDF ↗ |
| K261485 | Tetric plus Fill;Tetric plus Flow | Ivoclar Vivadent, Inc. | 2026-07-01 | Traditional | PDF ↗ |
| K261246 | SRGC-06 | GC America, Inc. | 2026-06-18 | Traditional | PDF ↗ |
| K261093 | DIAFIL | DiaDent Group International | 2026-06-02 | Traditional | PDF ↗ |
| K261071 | DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g) | DiaDent Group International | 2026-05-19 | Traditional | PDF ↗ |
| K260805 | Dual Core | Vericom Co., Ltd. | 2026-05-11 | Traditional | PDF ↗ |
| K261357 | Grandio disc multicolor | Voco GmbH | 2026-04-27 | Traditional | PDF ↗ |
| K261356 | Dura-Crown | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2026-04-27 | Special | PDF ↗ |
| K260152 | Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT) | Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda. | 2026-04-23 | Traditional | PDF ↗ |
| K260661 | Midas Restore | Sprintray, Inc. | 2026-04-15 | Traditional | PDF ↗ |
| K253036 | Light-curing Coloring Materials (ALCM) | Aidite (Qinhuangdao) Technology Co., Ltd. | 2026-04-06 | Traditional | PDF ↗ |
| K260783 | Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One | Kulzer, LLC | 2026-03-11 | Traditional | PDF ↗ |
| K254245 | ZAFIRA® | New Stetic, SA | 2026-03-03 | Traditional | PDF ↗ |
| K260170 | LumiCera | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2026-01-21 | Traditional | PDF ↗ |
| K252465 | Any-Core | Mediclus Co., Ltd. | 2025-12-05 | Traditional | PDF ↗ |
| K253513 | MultiMatch Flow Chameleon AntiMicrobial Composite | Premier Dental Products Company | 2025-11-07 | Traditional | PDF ↗ |
| K253236 | G-BLOCK | Graphenano Dental S.L. | 2025-09-29 | Abbreviated | PDF ↗ |
| K253053 | Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2025-09-23 | Traditional | PDF ↗ |
| K251946 | G aenial Universal Injectable II | GC America, Inc. | 2025-08-29 | Traditional | PDF ↗ |
| K251283 | Once-Fil Flow | Mediclus Co., Ltd. | 2025-06-06 | Traditional | PDF ↗ |
| K250317 | EsFlow PLUS | Spident Co., Ltd. | 2025-05-30 | Traditional | PDF ↗ |
| K251578 | BEAUTIFIL II | Shofu Dental Corporation | 2025-05-27 | Traditional | PDF ↗ |
| K250778 | Sil-Flow | Dsi Dental Solutions, Ltd. | 2025-05-23 | Traditional | PDF ↗ |
| K251239 | GrandioSO Unlimited | Voco GmbH | 2025-05-21 | Special | PDF ↗ |
| K250763 | Reon | C.E.I.B.Med | 2025-05-12 | Traditional | PDF ↗ |
| K250497 | Additive Manufacturing (Light Curing) Crown Bridge Resin | Aidite (Qinhuangdao) Technology Co., Ltd. | 2025-04-30 | Traditional | PDF ↗ |
| K250823 | Any-Com Flow | Mediclus Co., Ltd. | 2025-04-14 | Special | PDF ↗ |
| 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 Syringe (15064); Visalys® Bulk Flow 15 x 0.25 g Caps (15066); Visalys® Bulk Flow Intro pack (15067); Visalys® Bulk Intro pack (15068) | Kettenbach GmbH & Co. KG | 2025-03-14 | Traditional | PDF ↗ |
| K242713 | Any-Com Bulk | Mediclus Co., Ltd. | 2025-02-07 | Traditional | PDF ↗ |
| K242572 | TopCEM-Try in Veneer Try-in Gel | Rizhao Huge Biomaterials Company, Ltd. | 2024-12-20 | Traditional | PDF ↗ |
| K243720 | 3Delta UNlimited | Deltamed GmbH | 2024-12-18 | Traditional | PDF ↗ |
| K242816 | Quantium | Bisco, Inc. | 2024-12-17 | Traditional | PDF ↗ |
| K233273 | C&B Ceramic; C&B Permanent; C&B Interim | Prevest Denpro Limited | 2024-11-27 | Traditional | PDF ↗ |
| K232994 | Vittra APS Unique Flow | Dentscare Ltda | 2024-10-18 | Traditional | PDF ↗ |
| K241131 | edelweiss CAD/CAM T-BLOCK; edelweiss CAD/CAM C-BLOCK; edelweiss CAD/CAM i-BLOCK; Ceramir CAD/CAM T-BLOCK; Ceramir CAD/CAM C-BLOCK; Ceramir CAD/CAM i-BLOCK | Edelweiss Dentistry Products GmbH | 2024-10-18 | Traditional | PDF ↗ |
| K241673 | Denture Base Resin (PN-Denture (Red, White)) | Shenzhen Piocreat 3D Technology Co., Ltd. | 2024-10-15 | Traditional | PDF ↗ |
| K242097 | DenMat Bulk Fill Composite | Den-Mat Holdings, LLC | 2024-10-15 | Traditional | PDF ↗ |
| K242014 | Jet Flow Bulk | Meta Biomed Co., Ltd. | 2024-10-08 | Traditional | PDF ↗ |
| K242277 | Crown HT | Sprintray, Inc. | 2024-10-01 | Traditional | PDF ↗ |
| K241147 | Any-Com | Mediclus Co., Ltd. | 2024-09-26 | Traditional | PDF ↗ |
| K240660 | Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-active | Kulzer, LLC | 2024-09-17 | Traditional | PDF ↗ |
| K232559 | C&B NFH Hybrid | Arum Dentistry Co., Ltd. | 2024-09-11 | Traditional | PDF ↗ |
| K240823 | els extra low shrinkage® composite & els extra low shrinkage® flow | Saremco Dental AG | 2024-06-27 | Abbreviated | PDF ↗ |
| K231142 | Temporis, Irix Plus | Dws S.R.L. | 2024-04-25 | Traditional | PDF ↗ |
| K240112 | Light Cure Composite | Sincera Technology (Changchun) Co., Ltd. | 2024-03-15 | Traditional | PDF ↗ |
| K240694 | FORMA Composite (Shade A3D) | Ultradent Products, Inc. | 2024-03-15 | Traditional | PDF ↗ |
| K231263 | Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT | Prevest Denpro Limited | 2024-01-05 | Traditional | PDF ↗ |
| K233082 | TopCEM Dual Cure Resin Cement | Rizhao Huge Biomaterials Company, Ltd. | 2023-12-22 | Traditional | PDF ↗ |
| K232050 | saremco print BRIDGETEC | Saremco Dental AG | 2023-11-14 | Abbreviated | PDF ↗ |
| K233596 | VarseoSmile TriniQ | Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG | 2023-11-09 | Traditional | PDF ↗ |
| K233502 | TERA HARZ II | Graphy, Inc. | 2023-11-01 | Traditional | PDF ↗ |
| K230644 | Signum opaque F | Kulzer, LLC | 2023-09-07 | Traditional | PDF ↗ |
| K231523 | EsCom250 | Spident Co., Ltd. | 2023-07-24 | Traditional | PDF ↗ |
| K230877 | Admira Fusion 5 | Voco GmbH | 2023-07-13 | Traditional | PDF ↗ |
| K223742 | Dental Ceramic Blocks | Aidite (Qinhuangdao) Technology Co., Ltd. | 2023-03-08 | Traditional | PDF ↗ |
| K222445 | LC ChromeFlow | S&C Polymer Silicon- Und Composite Spezialitaten GmbH | 2023-03-06 | Traditional | PDF ↗ |
| K222623 | Digital Crown | Sprintray, Inc. | 2022-12-14 | Traditional | PDF ↗ |
| K223632 | Premier's MultiMatch Universal Chameleon Restorative Composite | Premier Dental Products Company | 2022-12-06 | Traditional | PDF ↗ |
| K222581 | Stela Automix System | Sdi Limited | 2022-10-28 | Traditional | PDF ↗ |
| K222583 | Stela Capsule System | Sdi Limited | 2022-10-28 | Traditional | PDF ↗ |
| K221510 | TrusFIL-Flow Flowable Composite Restorative | Rizhao Huge Biomaterials Company, Ltd. | 2022-10-12 | Traditional | PDF ↗ |
| K222435 | Renamel® Microhybrid ;Renamel® Flowable Microhybrid | Cosmedent, Inc. | 2022-10-11 | Traditional | PDF ↗ |
| K213339 | DENU Composite Resin, DENU Flow Resin | Hdi, Inc. | 2022-09-23 | Abbreviated | PDF ↗ |
| K222877 | FREEPRINT crown | Detax GmbH | 2022-09-23 | Traditional | PDF ↗ |
| K222723 | AMBARINO High-Class | Creamed GmbH & Co. Produktions- Und Handels KG | 2022-09-09 | Traditional | PDF ↗ |
| K221255 | SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow | Kerr Corporation | 2022-08-31 | Traditional | PDF ↗ |
| K220329 | G-CAM | Graphenano Dental S.L. | 2022-08-16 | Abbreviated | PDF ↗ |
| K220077 | IMICRYL Composite, Composite Flow Materials | Imicryl Dis Malzemeleri Sanayi VE Ticaret AS | 2022-08-09 | Traditional | PDF ↗ |
| K221909 | J-Temp | Ultradent Products, Inc. | 2022-07-01 | Traditional | PDF ↗ |
| K221695 | 3M Filtek Supreme Flowable Restorative | 3M Company Espe Dental Products | 2022-06-13 | Traditional | PDF ↗ |
| K202920 | OptiComp | Pac-Dent, Inc. | 2022-05-25 | Traditional | PDF ↗ |
| K220605 | Venus Bulk Flow ONE | Kulzer, LLC | 2022-04-21 | Special | PDF ↗ |
| K213343 | Saremco Print CROWNTEC | Saremco Dental AG | 2022-01-21 | Abbreviated | PDF ↗ |
| K211804 | 3Delta Crown | Deltamed GmbH | 2021-12-06 | Traditional | PDF ↗ |
| K211345 | C-30 Crown Kit | Perfect Fit Crowns, LLC | 2021-11-24 | Traditional | PDF ↗ |
| K210231 | Vittra APS Unique | Dentscare Ltda | 2021-10-14 | Traditional | PDF ↗ |
| K202063 | TrusFIL Universal Composite Restorative | Rizhao Huge Biomaterials Company, Ltd. | 2021-10-06 | Traditional | PDF ↗ |
| K210045 | ACTIVA PRESTO PACK | Pulpdent Corporation | 2021-09-22 | Traditional | PDF ↗ |
| K210412 | Pac-Dent Ceramic Nanohybrid Resin | Pac-Dent, Inc. | 2021-07-26 | Traditional | PDF ↗ |
| K210349 | TKO Composite Bite Turbo Gel | Reliance Orthodontic Products, Inc. | 2021-07-20 | Traditional | PDF ↗ |
| K202846 | TERA HARZ | Graphy, Inc. | 2021-07-15 | Traditional | PDF ↗ |
| K210421 | Diafil & Diafil Capsule | DiaDent Group International | 2021-06-28 | Special | PDF ↗ |
| K211259 | Renamel Bulkfill | Cosmedent, Inc. | 2021-06-24 | Traditional | PDF ↗ |
| K210977 | E-Dent 1000 | Envisiontec GmbH | 2021-05-25 | Traditional | PDF ↗ |
| K200470 | Shofu Block HC Hard | Shofu Dental Corporation | 2021-02-05 | Traditional | PDF ↗ |
| K203598 | Omnichroma Flow Bulk | Tokuyama Dental Corporation | 2021-02-03 | Traditional | PDF ↗ |
| K201707 | Opallis, Opallis Flow | Dentscare Ltda | 2020-12-22 | Traditional | PDF ↗ |
| K200155 | Bright High Flow | Genoss Co., Ltd. | 2020-11-30 | Traditional | PDF ↗ |
| K200156 | Bright Low Flow | Genoss Co., Ltd. | 2020-10-27 | Traditional | PDF ↗ |
| K201795 | Transcend | Ultradent Product, Inc. | 2020-09-28 | Abbreviated | PDF ↗ |
| K193537 | Omnichroma Flow | Tokuyama Dental Corporation | 2020-08-19 | Traditional | PDF ↗ |
| K201010 | Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite | Nobio , Ltd. | 2020-08-14 | Traditional | PDF ↗ |
| K201307 | VisCalor | Voco GmbH | 2020-07-08 | Special | PDF ↗ |
| K201668 | VarseoSmile Crown plus | Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG | 2020-06-23 | Traditional | PDF ↗ |
| K193496 | CharmFil | Dentkist, Inc. | 2020-05-06 | Traditional | PDF ↗ |
| K190139 | Zircos-Com | Bioden Co., Ltd. | 2020-04-24 | Traditional | PDF ↗ |
| K200294 | GrandioSO Light Flow | Voco GmbH | 2020-03-27 | Special | PDF ↗ |
Product code EBF · Class II · Dental. Data: openFDA.