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)
Top companies in EBF
| Company | 510(k)s | Recalls |
|---|---|---|
| Kerr Corp. | 9 | 43 |
| Voco GmbH | 45 | 1 |
| Sybron Dental Specialties | 28 | 7 |
| Bisco, Inc. | 30 | 0 |
| Pulpdent Corp. | 29 | 0 |
| Scientific Pharmaceuticals, Inc. | 29 | 0 |
| Dentsply Intl. | 28 | 0 |
| Ivoclar North America, Inc. | 28 | 0 |
| Shofu Dental Corp. | 27 | 0 |
| GC America, Inc. | 24 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 25, 2020 | K192284 | DiaFil Flow DiaDent Group International, KR | EBF |
| Mar 20, 2020 | K192510 | DIAFIL & DIAFIL Capsule DiaDent Group International, KR | EBF |
| Mar 5, 2020 | K191991 | Ezfil Meta Biomed Co., Ltd., KR | EBF |
| Feb 25, 2020 | K191389 | Allcem Veneer APS Dentscare Ltda, BR | EBF |
| Dec 20, 2019 | K192178 | R&D Series Nova Compo N Imicryl Dis Malzemeleri Sanayi VE Ticaret AS, TR | EBF |
| Dec 16, 2019 | K191306 | Llis, Vittra APS Dentscare Ltda, BR | EBF |
| Nov 22, 2019 | K192260 | everX Flow GC America, Inc. | EBF |
| Nov 18, 2019 | K191980 | CLEARFIL MAJESTY ES Flow Kuraray Noritake Dental, Inc., JP | EBF |
| Oct 29, 2019 | K191385 | BRILLIANT COMPONEER Coltene/Whaledent AG, CH | EBF |
| Sep 13, 2019 | K182921 | Infinix Universal Composite Nobio , Ltd., IL | EBF |
| Sep 4, 2019 | K190758 | Opus Bulk Fill APS, Opus Bulk Fill Flow APS Dentscare Ltda, BR | EBF |
| Jul 12, 2019 | K182714 | Novidia Bulk Fill Flow Composite Nobio , Ltd., IL | EBF |
| Jul 3, 2019 | K182780 | XP Composite S&C Polymer Silicon- Und Composite Spezialitaeten GmbH, DE | EBF |
| Jul 3, 2019 | K182580 | Novidia Flowable Composite Nobio , Ltd., IL | EBF |
| Jun 21, 2019 | K190597 | BRILLIANT EverGlow Flow Coltene/Whaledent AG, CH | EBF |
| May 3, 2019 | K182430 | CLEARFIL MAJESTY IC Kuraray Noritake Dental, Inc., JP | EBF |
| Apr 22, 2019 | K182778 | LC GLOSSFILL XR S&C Polymer Silicon- Und Composite Spezialitaeten GmbH, DE | EBF |
| Apr 11, 2019 | K190453 | VisCalor bulk Voco GmbH, DE | EBF |
| Mar 14, 2019 | K183380 | Tetric PowerFill Ivoclar Vivadent, AG, LI | EBF |
| Jan 9, 2019 | K182869 | Fit SA Shofu Dental Corporation | EBF |
| Jan 2, 2019 | K183476 | 3M Filtek Universal Restorative 3M Espe Dental Products | EBF |
| Dec 14, 2018 | K182296 | HyperFil-LV Parkell, Inc. | EBF |
| Nov 20, 2018 | K182288 | TPH Spectra ST Flowable Composite Restorative Dentsply Sirona | EBF |
| Nov 15, 2018 | K181689 | Nexcomp Meta Biomed Co., Ltd., KR | EBF |
| Nov 14, 2018 | K180463 | Apoller Flow Light Cure Flowable Composite Greenway Yw, LLC | EBF |
| Aug 22, 2018 | K181312 | GrandioSO x-tra Voco GmbH, DE | EBF |
| Aug 15, 2018 | K181500 | BRILLIANT Crios Coltene/Whaledent AG, CH | EBF |
| Jul 12, 2018 | K180613 | Estelite Universal Flow Tokuyama Dental Corporation, JP | EBF |
| Jul 3, 2018 | K172952 | Figaro Crowns Anterior Crown Kit, Figaro Crowns Posterior Crown Kit Figaro Crowns, Inc. | EBF |
| Jun 18, 2018 | K181484 | Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral Tissue Zirkonzahn Srl, IT | EBF |
| Jun 11, 2018 | K180649 | BeautiCem Veneer Kit Shofu Dental Corporation | EBF |
| Jun 7, 2018 | K173573 | Tetric CAD Ivoclar Vivadent, AG, LI | EBF |
| Mar 8, 2018 | K173500 | NMF004A GC America, Inc. | EBF |
| Feb 27, 2018 | K173275 | OMNICHROMA Tokuyama Dental Corporation, JP | EBF |
| Feb 24, 2018 | K173643 | Trilor Disks, Blocks and Arches Bioloren S.R.L., IT | EBF |
| Jan 31, 2018 | K171772 | Ecosite Bulk Fill Dmg USA, Inc. | EBF |
| Dec 18, 2017 | K173124 | PEEK Biosolution Merz Dental GmbH, DE | EBF |
| Dec 6, 2017 | K172530 | BEAUTIFIL Flow Plus X Shofu Dental Corporation | EBF |
| Dec 5, 2017 | K172707 | Renamel Microfill Cosmedent, Inc. | EBF |
| Nov 15, 2017 | K171815 | Registrado Scan Voco GmbH, DE | EBF |
| Nov 13, 2017 | K170102 | Pekkton Ivory Cendres+Metaux SA, CH | EBF |
| Oct 2, 2017 | K170873 | Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi Opaque Posterior, Medi White Pearl Swissmeditec GmbH, CH | EBF |
| Aug 10, 2017 | K171200 | Grandio blocs Voco GmbH, DE | EBF |
| Aug 4, 2017 | K171147 | REVEAL Bulk Bisco, Inc. | EBF |
| Jun 29, 2017 | K170896 | Admira Fusion x-base Voco GmbH, DE | EBF |
| Apr 3, 2017 | K161353 | ESTELITE BULK FILL Flow Tokuyama Dental Corporation, JP | EBF |
| Mar 24, 2017 | K162967 | nuance UNIVERSAL Den-Mat Holdings, LLC | EBF |
| Mar 17, 2017 | K163346 | MAZIC Duro Vericom Co., Ltd., KR | EBF |
| Feb 24, 2017 | K163480 | Renamel NANO +plus Cosmedent, Inc. | EBF |
| Jan 12, 2017 | K162323 | Tooth Shade Resin Material Liaoning Upcera Co., Ltd., CN | EBF |
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