ClearanceBrief
Panels › Dental › Product code EBF · Class 2

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)
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Top companies in EBF

Company510(k)sRecalls
Kerr Corp.943
Voco GmbH451
Sybron Dental Specialties287
Bisco, Inc.300
Pulpdent Corp.290
Scientific Pharmaceuticals, Inc.290
Dentsply Intl.280
Ivoclar North America, Inc.280
Shofu Dental Corp.270
GC America, Inc.240
Decided510(k)Device and applicantCode
Dec 22, 2023K233082TopCEM Dual Cure Resin Cement
Rizhao Huge Biomaterials Company, Ltd., CN
EBF
Nov 14, 2023K232050saremco print BRIDGETEC
Saremco Dental AG, CH
EBF
Nov 9, 2023K233596VarseoSmile TriniQ
Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG, DE
EBF
Nov 1, 2023K233502TERA HARZ II
Graphy, Inc., KR
EBF
Sep 7, 2023K230644Signum opaque F
Kulzer, LLC
EBF
Jul 24, 2023K231523EsCom250
Spident Co., Ltd., KR
EBF
Jul 13, 2023K230877Admira Fusion 5
Voco GmbH, DE
EBF
Mar 8, 2023K223742Dental Ceramic Blocks
Aidite (Qinhuangdao) Technology Co., Ltd., CN
EBF
Mar 6, 2023K222445LC ChromeFlow
S&C Polymer Silicon- Und Composite Spezialitaten GmbH, DE
EBF
Dec 14, 2022K222623Digital Crown
Sprintray, Inc.
EBF
Dec 6, 2022K223632Premier's MultiMatch Universal Chameleon Restorative Composite
Premier Dental Products Company
EBF
Oct 28, 2022K222583Stela Capsule System
Sdi Limited, AU
EBF
Oct 28, 2022K222581Stela Automix System
Sdi Limited, AU
EBF
Oct 12, 2022K221510TrusFIL-Flow Flowable Composite Restorative
Rizhao Huge Biomaterials Company, Ltd., CN
EBF
Oct 11, 2022K222435Renamel® Microhybrid ;Renamel® Flowable Microhybrid
Cosmedent, Inc.
EBF
Sep 23, 2022K222877FREEPRINT crown
Detax GmbH, DE
EBF
Sep 23, 2022K213339DENU Composite Resin, DENU Flow Resin
Hdi, Inc., KR
EBF
Sep 9, 2022K222723AMBARINO High-Class
Creamed GmbH & Co. Produktions- Und Handels KG, DE
EBF
Aug 31, 2022K221255SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow
Kerr Corporation
EBF
Aug 16, 2022K220329G-CAM
Graphenano Dental S.L., ES
EBF
Aug 9, 2022K220077IMICRYL Composite, Composite Flow Materials
Imicryl Dis Malzemeleri Sanayi VE Ticaret AS, TR
EBF
Jul 1, 2022K221909J-Temp
Ultradent Products, Inc.
EBF
Jun 13, 2022K2216953M Filtek Supreme Flowable Restorative
3M Company Espe Dental Products
EBF
May 25, 2022K202920OptiComp
Pac-Dent, Inc.
EBF
Apr 21, 2022K220605Venus Bulk Flow ONE
Kulzer, LLC
EBF
Jan 21, 2022K213343Saremco Print CROWNTEC
Saremco Dental AG, CH
EBF
Dec 6, 2021K2118043Delta Crown
Deltamed GmbH, DE
EBF
Nov 24, 2021K211345C-30 Crown Kit
Perfect Fit Crowns, LLC
EBF
Oct 14, 2021K210231Vittra APS Unique
Dentscare Ltda, BR
EBF
Oct 6, 2021K202063TrusFIL Universal Composite Restorative
Rizhao Huge Biomaterials Company, Ltd., CN
EBF
Sep 22, 2021K210045ACTIVA PRESTO PACK
Pulpdent Corporation
EBF
Jul 26, 2021K210412Pac-Dent Ceramic Nanohybrid Resin
Pac-Dent, Inc.
EBF
Jul 20, 2021K210349TKO Composite Bite Turbo Gel
Reliance Orthodontic Products, Inc.
EBF
Jul 15, 2021K202846TERA HARZ
Graphy, Inc., KR
EBF
Jun 28, 2021K210421Diafil & Diafil Capsule
DiaDent Group International, KR
EBF
Jun 24, 2021K211259Renamel Bulkfill
Cosmedent, Inc.
EBF
May 25, 2021K210977E-Dent 1000
Envisiontec GmbH, DE
EBF
Feb 5, 2021K200470Shofu Block HC Hard
Shofu Dental Corporation
EBF
Feb 3, 2021K203598Omnichroma Flow Bulk
Tokuyama Dental Corporation, JP
EBF
Dec 22, 2020K201707Opallis, Opallis Flow
Dentscare Ltda, BR
EBF
Nov 30, 2020K200155Bright High Flow
Genoss Co., Ltd., KR
EBF
Oct 27, 2020K200156Bright Low Flow
Genoss Co., Ltd., KR
EBF
Sep 28, 2020K201795Transcend
Ultradent Product, Inc.
EBF
Aug 19, 2020K193537Omnichroma Flow
Tokuyama Dental Corporation, JP
EBF
Aug 14, 2020K201010Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite
Nobio , Ltd., IL
EBF
Jul 8, 2020K201307VisCalor
Voco GmbH, DE
EBF
Jun 23, 2020K201668VarseoSmile Crown plus
Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG, DE
EBF
May 6, 2020K193496CharmFil
Dentkist, Inc., KR
EBF
Apr 24, 2020K190139Zircos-Com
Bioden Co., Ltd., KR
EBF
Mar 27, 2020K200294GrandioSO Light Flow
Voco GmbH, DE
EBF

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