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 2 of 10
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K192284 | DiaFil Flow | DiaDent Group International | 2020-03-25 | Traditional | PDF ↗ |
| K192510 | DIAFIL & DIAFIL Capsule | DiaDent Group International | 2020-03-20 | Traditional | PDF ↗ |
| K191991 | Ezfil | Meta Biomed Co., Ltd. | 2020-03-05 | Traditional | PDF ↗ |
| K191389 | Allcem Veneer APS | Dentscare Ltda | 2020-02-25 | Traditional | PDF ↗ |
| K192178 | R&D Series Nova Compo N | Imicryl Dis Malzemeleri Sanayi VE Ticaret AS | 2019-12-20 | Traditional | PDF ↗ |
| K191306 | Llis, Vittra APS | Dentscare Ltda | 2019-12-16 | Traditional | PDF ↗ |
| K192260 | everX Flow | GC America, Inc. | 2019-11-22 | Traditional | PDF ↗ |
| K191980 | CLEARFIL MAJESTY ES Flow | Kuraray Noritake Dental, Inc. | 2019-11-18 | Traditional | PDF ↗ |
| K191385 | BRILLIANT COMPONEER | Coltene/Whaledent AG | 2019-10-29 | Traditional | PDF ↗ |
| K182921 | Infinix Universal Composite | Nobio , Ltd. | 2019-09-13 | Traditional | PDF ↗ |
| K190758 | Opus Bulk Fill APS, Opus Bulk Fill Flow APS | Dentscare Ltda | 2019-09-04 | Traditional | PDF ↗ |
| K182714 | Novidia Bulk Fill Flow Composite | Nobio , Ltd. | 2019-07-12 | Traditional | PDF ↗ |
| K182780 | XP Composite | S&C Polymer Silicon- Und Composite Spezialitaeten GmbH | 2019-07-03 | Traditional | PDF ↗ |
| K182580 | Novidia Flowable Composite | Nobio , Ltd. | 2019-07-03 | Traditional | PDF ↗ |
| K190597 | BRILLIANT EverGlow Flow | Coltene/Whaledent AG | 2019-06-21 | Traditional | PDF ↗ |
| K182430 | CLEARFIL MAJESTY IC | Kuraray Noritake Dental, Inc. | 2019-05-03 | Traditional | PDF ↗ |
| K182778 | LC GLOSSFILL XR | S&C Polymer Silicon- Und Composite Spezialitaeten GmbH | 2019-04-22 | Traditional | PDF ↗ |
| K190453 | VisCalor bulk | Voco GmbH | 2019-04-11 | Special | PDF ↗ |
| K183380 | Tetric PowerFill | Ivoclar Vivadent, AG | 2019-03-14 | Abbreviated | PDF ↗ |
| K182869 | Fit SA | Shofu Dental Corporation | 2019-01-09 | Traditional | PDF ↗ |
| K183476 | 3M Filtek Universal Restorative | 3M Espe Dental Products | 2019-01-02 | Traditional | PDF ↗ |
| K182296 | HyperFil-LV | Parkell, Inc. | 2018-12-14 | Traditional | PDF ↗ |
| K182288 | TPH Spectra ST Flowable Composite Restorative | Dentsply Sirona | 2018-11-20 | Traditional | PDF ↗ |
| K181689 | Nexcomp | Meta Biomed Co., Ltd. | 2018-11-15 | Traditional | PDF ↗ |
| K180463 | Apoller Flow Light Cure Flowable Composite | Greenway Yw, LLC | 2018-11-14 | Abbreviated | PDF ↗ |
| K181312 | GrandioSO x-tra | Voco GmbH | 2018-08-22 | Traditional | PDF ↗ |
| K181500 | BRILLIANT Crios | Coltene/Whaledent AG | 2018-08-15 | Traditional | PDF ↗ |
| K180613 | Estelite Universal Flow | Tokuyama Dental Corporation | 2018-07-12 | Traditional | PDF ↗ |
| K172952 | Figaro Crowns Anterior Crown Kit, Figaro Crowns Posterior Crown Kit | Figaro Crowns, Inc. | 2018-07-03 | Traditional | PDF ↗ |
| K181484 | Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral Tissue | Zirkonzahn Srl | 2018-06-18 | Traditional | PDF ↗ |
| K180649 | BeautiCem Veneer Kit | Shofu Dental Corporation | 2018-06-11 | Traditional | PDF ↗ |
| K173573 | Tetric CAD | Ivoclar Vivadent, AG | 2018-06-07 | Abbreviated | PDF ↗ |
| K173500 | NMF004A | GC America, Inc. | 2018-03-08 | Traditional | PDF ↗ |
| K173275 | OMNICHROMA | Tokuyama Dental Corporation | 2018-02-27 | Traditional | PDF ↗ |
| K173643 | Trilor Disks, Blocks and Arches | Bioloren S.R.L. | 2018-02-24 | Special | PDF ↗ |
| K171772 | Ecosite Bulk Fill | Dmg USA, Inc. | 2018-01-31 | Traditional | PDF ↗ |
| K173124 | PEEK Biosolution | Merz Dental GmbH | 2017-12-18 | Traditional | PDF ↗ |
| K172530 | BEAUTIFIL Flow Plus X | Shofu Dental Corporation | 2017-12-06 | Traditional | PDF ↗ |
| K172707 | Renamel Microfill | Cosmedent, Inc. | 2017-12-05 | Traditional | PDF ↗ |
| K171815 | Registrado Scan | Voco GmbH | 2017-11-15 | Traditional | PDF ↗ |
| K170102 | Pekkton Ivory | Cendres+Metaux SA | 2017-11-13 | Traditional | PDF ↗ |
| K170873 | Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi Opaque Posterior, Medi White Pearl | Swissmeditec GmbH | 2017-10-02 | Traditional | PDF ↗ |
| K171200 | Grandio blocs | Voco GmbH | 2017-08-10 | Traditional | PDF ↗ |
| K171147 | REVEAL Bulk | Bisco, Inc. | 2017-08-04 | Traditional | PDF ↗ |
| K170896 | Admira Fusion x-base | Voco GmbH | 2017-06-29 | Traditional | PDF ↗ |
| K161353 | ESTELITE BULK FILL Flow | Tokuyama Dental Corporation | 2017-04-03 | Traditional | PDF ↗ |
| K162967 | nuance UNIVERSAL | Den-Mat Holdings, LLC | 2017-03-24 | Traditional | PDF ↗ |
| K163346 | MAZIC Duro | Vericom Co., Ltd. | 2017-03-17 | Traditional | PDF ↗ |
| K163480 | Renamel NANO +plus | Cosmedent, Inc. | 2017-02-24 | Traditional | PDF ↗ |
| K162323 | Tooth Shade Resin Material | Liaoning Upcera Co., Ltd. | 2017-01-12 | Traditional | PDF ↗ |
| K162261 | CERAMAGE UP | Shofu Dental Corporation | 2017-01-11 | Traditional | PDF ↗ |
| K163207 | Filtek One Bulk Fill Restorative | 3M Company | 2016-11-28 | Traditional | PDF ↗ |
| K162537 | CAD/CAMouflage Milling Block | Prismatik Dentalcraft, Inc. | 2016-11-16 | Special | PDF ↗ |
| K160049 | Charisma | Heraeus Kulzer, LLC (Mitsui Chemicals Group) | 2016-11-15 | Traditional | PDF ↗ |
| K162257 | P1145 Dental Restorative | Kerr Corporation | 2016-11-07 | Traditional | PDF ↗ |
| K151399 | Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq Flow | Schutz Dental GmbH | 2016-10-24 | Traditional | PDF ↗ |
| K162107 | TPH Spectra+ Universal Composite Restorative | Dentsply Sirona | 2016-09-27 | Traditional | PDF ↗ |
| K153476 | KATANA AVENCIA Block | Kuraray Noritake Dental, Inc. | 2016-08-23 | Traditional | PDF ↗ |
| K152471 | CAPO BULK FILL | Schuetz Dental GmbH | 2016-08-04 | Traditional | PDF ↗ |
| K153493 | Clip Flow | Voco GmbH | 2016-07-29 | Traditional | PDF ↗ |
| K160596 | BEAUTIFIL II LS | Shofu Dental Corporation | 2016-07-27 | Traditional | PDF ↗ |
| K160086 | SHOFU Enamel Conditioner | Shofu Dental Corporation | 2016-07-21 | Traditional | PDF ↗ |
| K152113 | BioHPP - breCAM.BioHPP | Bredent GmbH & Co. KG | 2016-07-21 | Traditional | PDF ↗ |
| K160425 | CAD/CAMouflage Milling Bock | Prismatik Dentalcraft, Inc. | 2016-07-15 | Traditional | PDF ↗ |
| K153325 | Gradia Plus | GC America, Inc. | 2016-07-12 | Traditional | PDF ↗ |
| K153177 | Admira Fusion Flow | Voco GmbH | 2016-06-30 | Traditional | PDF ↗ |
| K153127 | everX Posterior | GC America, Inc. | 2016-05-20 | Traditional | PDF ↗ |
| K152927 | BRILLIANT EVERGLOW | Coltene/Whaledent AG | 2016-04-28 | Traditional | PDF ↗ |
| K153249 | Pulpdent Solo Flowable Composite with MCP | Pulpdent Corporation | 2016-04-01 | Traditional | PDF ↗ |
| K151700 | BEAUTIFIL II Gingiva | Shofu Dental Corporation | 2016-03-02 | Traditional | PDF ↗ |
| K153191 | Calcium Bridge | Denali Corporation | 2016-02-26 | Traditional | PDF ↗ |
| K152373 | VITA VM LC Flow | Vita Zahnfabrik H.Rauter GmbH & Co. | 2015-12-30 | Abbreviated | PDF ↗ |
| K151699 | BEAUTIFIL II Enamel | Shofu Dental Corporation | 2015-12-10 | Traditional | PDF ↗ |
| K152004 | Nanova Universal Composite | Nanova Biomaterials, Inc. | 2015-11-17 | Traditional | PDF ↗ |
| K151956 | Admira Fusion x-tra | Voco GmbH | 2015-10-20 | Traditional | PDF ↗ |
| K151541 | G-Fix | GC America, Inc. | 2015-10-09 | Traditional | PDF ↗ |
| K151514 | Prestige | Danville Materials, LLC | 2015-09-21 | Traditional | PDF ↗ |
| K151088 | DMRC Bulk Fill | Danville Materials, LLC | 2015-08-28 | Traditional | PDF ↗ |
| K151094 | Mosaic Universal Composite | Ultradent Products, Inc. | 2015-07-21 | Traditional | PDF ↗ |
| K150784 | Admira Fusion | Voco GmbH | 2015-07-02 | Traditional | PDF ↗ |
| K150218 | Fill-Up! | Coltene/Whaledent AG | 2015-06-23 | Traditional | PDF ↗ |
| K150623 | Nanova Flowable Composite | Nanova Biomaterials, Inc. | 2015-06-18 | Traditional | PDF ↗ |
| K150393 | TETRIC EVOFLOW BULK FILL | Ivoclar Vivadent, AG | 2015-06-09 | Abbreviated | PDF ↗ |
| K143524 | Fiber Disks and Blocks (TRINIA) | Bicon, LLC | 2015-06-02 | Traditional | PDF ↗ |
| K143694 | Rhondium One-Visit-Crown(OVC) | Rhondium, Ltd. | 2015-05-15 | Traditional | PDF ↗ |
| K143679 | Nuance FLOW | Den-Mat Holdings, LLC | 2015-05-01 | Traditional | PDF ↗ |
| K143104 | Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-X | Kettenbach GmbH & Co. KG | 2015-03-25 | Traditional | PDF ↗ |
| K143209 | SonicFill 2 | Sybron Dental Specialties | 2015-02-05 | Traditional | PDF ↗ |
| K142389 | Variolink Esthetic | Ivoclar Vivadent, AG | 2014-11-25 | Abbreviated | PDF ↗ |
| K141994 | BULK FILL FLOWABLE COMPOSITE | Novocol, Inc. | 2014-11-14 | Traditional | PDF ↗ |
| K140976 | ENADEN FLOW | Km Corporation | 2014-07-10 | Traditional | PDF ↗ |
| K140512 | UFILL BULK FILL POSTERIOR FLOWABLE COMPOSITE | Juno Dentistry LP | 2014-07-02 | Traditional | PDF ↗ |
| K132115 | ABSOLUTE DENTIN 2 | Parkell, Inc. | 2014-06-25 | Traditional | PDF ↗ |
| K133850 | CAMOUFLAGE NANOHYBRID COMPOSITE (UNIVERSAL & FLOWABLE) | Prismatik Dentalcraft, Inc. | 2014-06-04 | Traditional | PDF ↗ |
| K141081 | FILTEK BULK FILL POSTERIOR RESTROATIVE | 3M Espe Dental Products | 2014-05-08 | Traditional | PDF ↗ |
| K133182 | HTFX-222 | GC America, Inc. | 2014-04-09 | Traditional | PDF ↗ |
| K133608 | TRINIA | Bicon, LLC | 2014-03-14 | Abbreviated | PDF ↗ |
| K133824 | CERASMART | GC America, Inc. | 2014-03-14 | Traditional | PDF ↗ |
| K132748 | BEAUTIFIL E POSTERIOR, BEAUTIFIL BULK | Shofu Dental Corporation | 2013-12-04 | Traditional | PDF ↗ |
| K131753 | MERIDIAN | Ab Ardent | 2013-11-14 | Abbreviated | PDF ↗ |
Product code EBF · Class II · Dental. Data: openFDA.