Resin, Denture, Relining, Repairing, Rebasing
Regulation 872.3760
10510(k)s in 12 months (335 all time)
0recalls in 12 months (16 all time)
10recalls that name a 510(k)
Top companies in EBI
| Company | 510(k)s | Recalls |
|---|---|---|
| Dentsply Intl. | 16 | 0 |
| Heraeus Kulzer, Inc. | 13 | 0 |
| GC America, Inc. | 12 | 0 |
| Cmp Industries, LLC | 5 | 6 |
| Harry J. Bosworth Co. | 8 | 0 |
| Lang Dental Mfg. Co., Inc. | 7 | 1 |
| Voco GmbH | 8 | 0 |
| Vertex-Dental B.V. | 7 | 0 |
| Dentsply Sirona | 6 | 0 |
| Stick Tech , Ltd. | 6 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 5, 2021 | K210298 | GR-14 Resin System Pro3Dure Medical GmbH, DE | EBI |
| Mar 30, 2021 | K203641 | E-Denture Pro Envisiontec GmbH, DE | EBI |
| Mar 23, 2021 | K210828 | DIOnavi-Denture02 Dio Corporation, KR | EBI |
| Nov 19, 2020 | K200580 | FotoDent denture Dreve Dentamid GmbH, DE | EBI |
| Nov 16, 2020 | K200461 | Freeprint denture Detax GmbH & Co. KG, DE | EBI |
| Oct 22, 2020 | K193623 | DIOnavi-Denture Dio Corporation, KR | EBI |
| Aug 18, 2020 | K191591 | BB Base 3D printing resin for denture base Enlighten Materials Co., Ltd., TW | EBI |
| Jul 31, 2020 | K190790 | Flex Fit Dk Mungyo Corporation, KR | EBI |
| Jan 29, 2020 | K191926 | VITA VIONIC Bond Vita Zanhnfabrik H. Rauter GmbH Co., DE | EBI |
| Nov 1, 2019 | K191497 | NextDent Denture 3D+ Vertex-Dental B.V., NL | EBI |
| Oct 4, 2019 | K190940 | Tokuyama Rebase III Tokuyama Dental Corporation, JP | EBI |
| Aug 26, 2019 | K191427 | Halley resin system Dentsply Sirona | EBI |
| Apr 24, 2019 | K190043 | Halley resin Dentsply Sirona | EBI |
| Dec 21, 2018 | K181331 | JUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster White Juvora, Ltd., GB | EBI |
| Dec 18, 2018 | K182422 | Lucitone Denture Base Materials Dentsply Sirona | EBI |
| Oct 12, 2018 | K181220 | Juell 3D Volo Base Park Dental Research Corporation | EBI |
| Apr 27, 2018 | K172764 | Keymill Mycone Dental Supply Company, Inc. (Aka Keystone Industries) | EBI |
| Jan 16, 2018 | K172683 | Yamahachi Pink CAD/CAM Disk YAMAHACHI DENTAL MFG., Co., JP | EBI |
| Nov 2, 2017 | K172407 | Duracetal The Myerson Company Limited, TT | EBI |
| Oct 2, 2017 | K170375 | Nobilplast Denture Resin Cmp Industries, LLC | EBI |
| Jul 5, 2017 | K170549 | TOKUYAMA CUREGRACE Tokuyama Dental Corporation, JP | EBI |
| Jun 30, 2017 | K162572 | NextDent Denture, E-Denture Vertex-Dental B.V., NL | EBI |
| May 31, 2017 | K163482 | Orthodontic Acrylic 2 Lang Dental Manufacturing Co., Inc. | EBI |
| Mar 13, 2017 | K162654 | mollosil plus Detax GmbH & Co. KG, DE | EBI |
| Mar 3, 2017 | K162044 | Dentca Denture Base II Dentca, Inc. | EBI |
| Feb 13, 2017 | K160918 | JUVORA Dental Disc, Ceramill PEEK by JUVORA Juvora, GB | EBI |
| Oct 6, 2016 | K161330 | Pour Acrylic Dentsply Sirona | EBI |
| Sep 28, 2016 | K153546 | PINK CAD/CAM disc Polident D.O.O., Dental Products Industry, SI | EBI |
| Sep 2, 2016 | K152981 | JET SET 4 DENTURE REPAIR RESIN Lang Dental Manufacturing Company, Inc. | EBI |
| Jun 15, 2016 | K160498 | Dentivera Milling Disc Dental Solutions, LLC | EBI |
| Apr 22, 2016 | K153590 | AvaDent Denture Base Material Global Dental Science | EBI |
| Mar 22, 2016 | K152051 | ClearMet Mycone Dental Supply Co., T/A Keystone Industries | EBI |
| Mar 3, 2016 | K153253 | GC Reline II GC America, Inc. | EBI |
| Nov 13, 2015 | K152270 | Denture base resin Korea Engineering Plastics Co., Ltd., KR | EBI |
| Oct 21, 2015 | K151646 | ProTech Plus Protech Professional Products, Inc. | EBI |
| Aug 13, 2015 | K151142 | IVOBASE CAD FOR ZENOTEC, IVOBASE CAD BOND, IVOBASE CAD MODELLING LIQUID Wieland Dental + Technik GmbH & Co. KG, DE | EBI |
| Jul 21, 2015 | K143033 | DENTCA DENTURE BASE Dentca, Inc. | EBI |
| May 27, 2015 | K150511 | Coating Material Sun Medical Co., Ltd., JP | EBI |
| May 26, 2015 | K150454 | Acryfree Denture Base Material and Biosens Denture Base Material Perflex, IL | EBI |
| Apr 14, 2015 | K143265 | Acrylic Block Sun Medical Co., Ltd., JP | EBI |
| Feb 3, 2015 | K142894 | TCS Blend Thermoplastic Comfort Systems, Inc. | EBI |
| Jan 7, 2015 | K143486 | Ufi Gel hard C Voco GmbH, DE | EBI |
| Sep 15, 2014 | K140758 | M-PM-DISC (PINK) Merz Dental GmbH | EBI |
| Sep 12, 2014 | K141439 | ORTHODONTIC ACRYLIC (NOT FINALIZED) Bisco, Inc. | EBI |
| Jun 16, 2014 | K140570 | CHAIRSIDE ATTACHMENT PROCESSING MATERIAL Zest Anchors, LLC | EBI |
| Apr 29, 2014 | K140146 | COMFORTSOFT SOFT DENTURE LINER SYSTEM Whip Mix Corp. | EBI |
| Jan 23, 2014 | K132725 | JUVORA DENTQAL DISC Juvora, GB | EBI |
| Aug 22, 2013 | K130076 | PROMOLUX, PROMOLUX HI, WEROPRESS, PREMECO PCS Merz Dental GmbH | EBI |
| Jul 26, 2013 | K130680 | ACRYTONE, REZEN NF, AND ISO FAST DENTURE RESINS Dentsoll, Inc. | EBI |
| Jul 12, 2013 | K131036 | YAMAHACHI DENTURE BASE RESINS Yamahachi Dental Manufacturing Co. | EBI |
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