Product code EBF— Dental
GRANDIO FLOW
- Classification name
- Material, Tooth Shade, Resin
- Device class
- Class 2
- Regulation
- 21 CFR 872.3690
- Advisory panel
- Dental
- Total cleared
- 935
- First cleared
- Most recent
Market context for product code EBF
FDA has cleared devices under product code EBF between 1976 and 2026, filed by 236 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2025
- 2024
- 2023
- 2022
- 2021
- 2020
- 2019
- 2018
- 2017
- 2016
- 2015
- 2014
- 2013
- 2012
Top applicants under product code EBF
Recent clearances under product code EBF
1–100 of 935- K262202 — Cerasmart Forte
- K261695 — Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)
- K261485 — Tetric plus Fill; Tetric plus Flow
- K262228 — Transcend Bulk Fill Flowable Composite
- K261246 — SRGC-06
- K261093 — DIAFIL
- K261071 — DIAFIL Bulk FLOW (3 models)
- K260805 — Dual Core
- K261356 — Dura-Crown
- K261357 — Grandio disc multicolor
- K260152 — Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT)
- K253036 — Light-curing Coloring Materials (ALCM)
- K260783 — Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One
- K254245 — ZAFIRA®
- K260170 — LumiCera
- K252465 — Any-Core
- K253513 — MultiMatch Flow Chameleon AntiMicrobial Composite
- K253236 — G-BLOCK
- K253053 — Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1)
- K251946 — G aenial Universal Injectable II
- K251283 — Once-Fil Flow
- K250317 — EsFlow PLUS
- K251578 — BEAUTIFIL II
- K250778 — Sil-Flow
- K251239 — GrandioSO Unlimited
- K250763 — Reon
- K250497 — Additive Manufacturing (Light Curing) Crown Bridge Resin
- K250823 — Any-Com Flow
- K250267 — Visalys® Bulk Fill 1 x 4 g Syringe (15060) +5 more
- K242713 — Any-Com Bulk
- K242572 — TopCEM-Try in Veneer Try-in Gel
- K243720 — 3Delta UNlimited
- K242816 — Quantium
- K233273 — C&B Ceramic; C&B Permanent; C&B Interim
- K232994 — Vittra APS Unique Flow
- K241131 — edelweiss CAD/CAM T-BLOCK +5 more
- K241673 — Denture Base Resin (PN-Denture (Red, White))
- K242097 — DenMat Bulk Fill Composite
- K242014 — Jet Flow Bulk
- K242277 — Crown HT
- K241147 — Any-Com
- K240660 — Signum composite flow +6 more
- K232559 — C&B NFH Hybrid
- K240823 — els extra low shrinkage® composite & els extra low shrinkage® flow
- K231142 — Temporis, Irix Plus
- K240112 — Light Cure Composite
- K240694 — FORMA Composite (Shade A3D)
- K231263 — Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT
- K233082 — TopCEM Dual Cure Resin Cement
- K232050 — saremco print BRIDGETEC
- K233596 — VarseoSmile TriniQ
- K233502 — TERA HARZ II
- K230644 — Signum opaque F
- K231523 — EsCom250
- K230877 — Admira Fusion 5
- K223742 — Dental Ceramic Blocks
- K222445 — LC ChromeFlow
- K222623 — Digital Crown
- K223632 — Premier's MultiMatch Universal Chameleon Restorative Composite
- K222581 — Stela Automix System
- K222583 — Stela Capsule System
- K221510 — TrusFIL-Flow Flowable Composite Restorative
- K222435 — Renamel® Microhybrid; Renamel® Flowable Microhybrid
- K213339 — DENU Composite Resin, DENU Flow Resin
- K222877 — FREEPRINT crown
- K222723 — AMBARINO High-Class
- K221255 — SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow
- K220329 — G-CAM
- K220077 — IMICRYL Composite, Composite Flow Materials
- K221909 — J-Temp
- K221695 — 3M Filtek Supreme Flowable Restorative
- K202920 — OptiComp
- K220605 — Venus Bulk Flow ONE
- K213343 — Saremco Print CROWNTEC
- K211804 — 3Delta Crown
- K211345 — C-30 Crown Kit
- K210231 — Vittra APS Unique
- K202063 — TrusFIL Universal Composite Restorative
- K210045 — ACTIVA PRESTO PACK
- K210412 — Pac-Dent Ceramic Nanohybrid Resin
- K210349 — TKO Composite Bite Turbo Gel
- K202846 — TERA HARZ
- K210421 — Diafil & Diafil Capsule
- K211259 — Renamel Bulkfill
- K210977 — E-Dent 1000
- K200470 — Shofu Block HC Hard
- K203598 — Omnichroma Flow Bulk
- K201707 — Opallis, Opallis Flow
- K200155 — Bright High Flow
- K200156 — Bright Low Flow
- K201795 — Transcend
- K193537 — Omnichroma Flow
- K201010 — Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite
- K201307 — VisCalor
- K201668 — VarseoSmile Crown plus
- K193496 — CharmFil
- K190139 — Zircos-Com
- K200294 — GrandioSO Light Flow
- K192284 — DiaFil Flow
- K192510 — DIAFIL & DIAFIL Capsule
Data sourced from openFDA. This site is unofficial and independent of the FDA.