Atlas FDA

EBF

934 FDA 510(k) clearances · Product code

69 daysmedian time to decision
176 days90th percentile
934clearances measured

FDA profile

Official device name
Material, Tooth Shade, Resin
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3690
Medical specialty
Dental
Flags
Third-party review eligible
Adverse events (MAUDE)
2012: 62 · 2013: 246 · 2014: 195 · 2015: 119 · 2016: 143 · 2017: 42
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Tetric plus Fill;Tetric plus Flow (K261485)Ivoclar Vivadent, Inc.2026-07-01
Transcend Bulk Fill Flowable Composite (K262228)Ultradent Products, Inc.2026-07-01
SRGC-06 (K261246)GC America, Inc.2026-06-18
DIAFIL (K261093)DiaDent Group International2026-06-02
DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g) (K261071)DiaDent Group International2026-05-19
Dual Core (K260805)Vericom Co., Ltd.2026-05-11
Grandio disc multicolor (K261357)Voco GmbH2026-04-27
Dura-Crown (K261356)Hangzhou SHINING3D Dental Technology Co., Ltd.2026-04-27
Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT) (K260152)Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda.2026-04-23
Midas Restore (K260661)Sprintray, Inc.2026-04-15
Light-curing Coloring Materials (ALCM) (K253036)Aidite (Qinhuangdao) Technology Co., Ltd.2026-04-06
Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One (K260783)Kulzer, LLC2026-03-11
ZAFIRA® (K254245)New Stetic, SA2026-03-03
LumiCera (K260170)Hangzhou SHINING3D Dental Technology Co., Ltd.2026-01-21
Any-Core (K252465)Mediclus Co., Ltd.2025-12-05
MultiMatch Flow Chameleon AntiMicrobial Composite (K253513)Premier Dental Products Company2025-11-07
G-BLOCK (K253236)Graphenano Dental S.L.2025-09-29
Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) (K253053)Hangzhou SHINING3D Dental Technology Co., Ltd.2025-09-23
G aenial Universal Injectable II (K251946)GC America, Inc.2025-08-29
Once-Fil Flow (K251283)Mediclus Co., Ltd.2025-06-06
EsFlow PLUS (K250317)Spident Co., Ltd.2025-05-30
BEAUTIFIL II (K251578)Shofu Dental Corporation2025-05-27
Sil-Flow (K250778)Dsi Dental Solutions, Ltd.2025-05-23
GrandioSO Unlimited (K251239)Voco GmbH2025-05-21
Reon (K250763)C.E.I.B.Med2025-05-12
Additive Manufacturing (Light Curing) Crown Bridge Resin (K250497)Aidite (Qinhuangdao) Technology Co., Ltd.2025-04-30
Any-Com Flow (K250823)Mediclus Co., Ltd.2025-04-14
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) (K250267)Kettenbach GmbH & Co. KG2025-03-14
Any-Com Bulk (K242713)Mediclus Co., Ltd.2025-02-07
TopCEM-Try in Veneer Try-in Gel (K242572)Rizhao Huge Biomaterials Company, Ltd.2024-12-20
3Delta UNlimited (K243720)Deltamed GmbH2024-12-18
Quantium (K242816)Bisco, Inc.2024-12-17
C&B Ceramic; C&B Permanent; C&B Interim (K233273)Prevest Denpro Limited2024-11-27
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 (K241131)Edelweiss Dentistry Products GmbH2024-10-18
Vittra APS Unique Flow (K232994)Dentscare Ltda2024-10-18
DenMat Bulk Fill Composite (K242097)Den-Mat Holdings, LLC2024-10-15
Denture Base Resin (PN-Denture (Red, White)) (K241673)Shenzhen Piocreat 3D Technology Co., Ltd.2024-10-15
Jet Flow Bulk (K242014)Meta Biomed Co., Ltd.2024-10-08
Crown HT (K242277)Sprintray, Inc.2024-10-01
Any-Com (K241147)Mediclus Co., Ltd.2024-09-26
Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-active (K240660)Kulzer, LLC2024-09-17
C&B NFH Hybrid (K232559)Arum Dentistry Co., Ltd.2024-09-11
els extra low shrinkage® composite & els extra low shrinkage® flow (K240823)Saremco Dental AG2024-06-27
Temporis, Irix Plus (K231142)Dws S.R.L.2024-04-25
Light Cure Composite (K240112)Sincera Technology (Changchun) Co., Ltd.2024-03-15
FORMA Composite (Shade A3D) (K240694)Ultradent Products, Inc.2024-03-15
Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT (K231263)Prevest Denpro Limited2024-01-05
TopCEM Dual Cure Resin Cement (K233082)Rizhao Huge Biomaterials Company, Ltd.2023-12-22
saremco print BRIDGETEC (K232050)Saremco Dental AG2023-11-14
VarseoSmile TriniQ (K233596)Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG2023-11-09
TERA HARZ II (K233502)Graphy, Inc.2023-11-01
Signum opaque F (K230644)Kulzer, LLC2023-09-07
EsCom250 (K231523)Spident Co., Ltd.2023-07-24
Admira Fusion 5 (K230877)Voco GmbH2023-07-13
Dental Ceramic Blocks (K223742)Aidite (Qinhuangdao) Technology Co., Ltd.2023-03-08
LC ChromeFlow (K222445)S&C Polymer Silicon- Und Composite Spezialitaten GmbH2023-03-06
Digital Crown (K222623)Sprintray, Inc.2022-12-14
Premier's MultiMatch Universal Chameleon Restorative Composite (K223632)Premier Dental Products Company2022-12-06
Stela Capsule System (K222583)Sdi Limited2022-10-28
Stela Automix System (K222581)Sdi Limited2022-10-28
TrusFIL-Flow Flowable Composite Restorative (K221510)Rizhao Huge Biomaterials Company, Ltd.2022-10-12
Renamel® Microhybrid ;Renamel® Flowable Microhybrid (K222435)Cosmedent, Inc.2022-10-11
DENU Composite Resin, DENU Flow Resin (K213339)Hdi, Inc.2022-09-23
FREEPRINT crown (K222877)Detax GmbH2022-09-23
AMBARINO High-Class (K222723)Creamed GmbH & Co. Produktions- Und Handels KG2022-09-09
SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow (K221255)Kerr Corporation2022-08-31
G-CAM (K220329)Graphenano Dental S.L.2022-08-16
IMICRYL Composite, Composite Flow Materials (K220077)Imicryl Dis Malzemeleri Sanayi VE Ticaret AS2022-08-09
J-Temp (K221909)Ultradent Products, Inc.2022-07-01
3M Filtek Supreme Flowable Restorative (K221695)3M Company Espe Dental Products2022-06-13
OptiComp (K202920)Pac-Dent, Inc.2022-05-25
Venus Bulk Flow ONE (K220605)Kulzer, LLC2022-04-21
Saremco Print CROWNTEC (K213343)Saremco Dental AG2022-01-21
3Delta Crown (K211804)Deltamed GmbH2021-12-06
C-30 Crown Kit (K211345)Perfect Fit Crowns, LLC2021-11-24
Vittra APS Unique (K210231)Dentscare Ltda2021-10-14
TrusFIL Universal Composite Restorative (K202063)Rizhao Huge Biomaterials Company, Ltd.2021-10-06
ACTIVA PRESTO PACK (K210045)Pulpdent Corporation2021-09-22
Pac-Dent Ceramic Nanohybrid Resin (K210412)Pac-Dent, Inc.2021-07-26
TKO Composite Bite Turbo Gel (K210349)Reliance Orthodontic Products, Inc.2021-07-20
TERA HARZ (K202846)Graphy, Inc.2021-07-15
Diafil & Diafil Capsule (K210421)DiaDent Group International2021-06-28
Renamel Bulkfill (K211259)Cosmedent, Inc.2021-06-24
E-Dent 1000 (K210977)Envisiontec GmbH2021-05-25
Shofu Block HC Hard (K200470)Shofu Dental Corporation2021-02-05
Omnichroma Flow Bulk (K203598)Tokuyama Dental Corporation2021-02-03
Opallis, Opallis Flow (K201707)Dentscare Ltda2020-12-22
Bright High Flow (K200155)Genoss Co., Ltd.2020-11-30
Bright Low Flow (K200156)Genoss Co., Ltd.2020-10-27
Transcend (K201795)Ultradent Product, Inc.2020-09-28
Omnichroma Flow (K193537)Tokuyama Dental Corporation2020-08-19
Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite (K201010)Nobio , Ltd.2020-08-14
VisCalor (K201307)Voco GmbH2020-07-08
VarseoSmile Crown plus (K201668)Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG2020-06-23
CharmFil (K193496)Dentkist, Inc.2020-05-06
Zircos-Com (K190139)Bioden Co., Ltd.2020-04-24
GrandioSO Light Flow (K200294)Voco GmbH2020-03-27
DiaFil Flow (K192284)DiaDent Group International2020-03-25
DIAFIL & DIAFIL Capsule (K192510)DiaDent Group International2020-03-20
Ezfil (K191991)Meta Biomed Co., Ltd.2020-03-05
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