FDA Product Code
FDA Product Code EBI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.3760
510(k) Clearances — 335 records · page 1 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261802 | Glidewell Denture Base Resin | Prismatik Dentalcraft, Inc. | 2026-08-27 | Traditional | PDF ↗ |
| K261626 | UltraPrint Flexible Denture UV | Guangzhou Heygears IMC., Inc. | 2026-08-13 | Traditional | PDF ↗ |
| K262681 | NanoCeram Resin | 3BFAB TEKNOLOJI A.S. | 2026-07-31 | Traditional | PDF ↗ |
| K262300 | Denture Base Resin V2 | Formlabs Ohio, Inc. | 2026-07-08 | Abbreviated | PDF ↗ |
| K261474 | DENTCA Tru Flexible | Dentca, Inc. | 2026-07-01 | Traditional | PDF ↗ |
| K260569 | DB 4000 High Impact Denture Base | Carbon, Inc. | 2026-06-02 | Abbreviated | PDF ↗ |
| K260376 | Denture Base | Shandong Huge Dental Material Corporation | 2026-05-06 | Traditional | PDF ↗ |
| K253365 | LuxCreo Flexible Partial Denture Resin | LuxCreo, Inc. | 2025-11-25 | Traditional | PDF ↗ |
| K253681 | TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HARZ Hard Denture (THD-LP-500); TERA HARZ Hard Denture (THD-LP-1000); TERA HARZ Hard Denture (THD-P-500); TERA HARZ Hard Denture (THD-P-1000); TERA HARZ Hard Denture (THD-CP-500); TERA HARZ Hard Denture (THD-CP-1000) | Graphy, Inc. | 2025-11-21 | Traditional | PDF ↗ |
| K253324 | UltraPrint-Dental Denture UV | Guangzhou Heygears IMC., Inc. | 2025-11-20 | Traditional | PDF ↗ |
| K252430 | Freeprint® denture flex | Detax GmbH | 2025-10-30 | Traditional | PDF ↗ |
| K252035 | DENTURE SOFT EX (Pink set); DENTURE SOFT EX (White set); DENTURE SOFT EX (Pink powder); DENTURE SPFT EX (White powder); DENTURE SOFT EX (Liquid); DENTURE SOFT EX (Trial kit Pink); DENTURE SOFT EX (Trial kit White) | Kamemizu Chemical Industry Co., Ltd. | 2025-09-17 | Traditional | PDF ↗ |
| K250302 | Flexible Partial Resin | Prismatik Dentalcraft, Inc. | 2025-06-25 | Traditional | PDF ↗ |
| K242897 | Partial Flex | Clemde SA DE CV | 2025-06-03 | Traditional | PDF ↗ |
| K250489 | FP3D | Keystone Industries | 2025-05-20 | Traditional | PDF ↗ |
| K250617 | Apex Flex | Sprintray, Inc. | 2025-04-29 | Traditional | PDF ↗ |
| K243356 | Asiga DentaBASE | Asiga Pty, Ltd. | 2025-04-11 | Abbreviated | PDF ↗ |
| K250946 | Denture Base Resin DT20 | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2025-03-31 | Traditional | PDF ↗ |
| K243103 | Denture Base | Riton 3D Technology Co., Ltd. | 2024-12-23 | Traditional | PDF ↗ |
| K243336 | Lucitone Digital Print Denture System | Dentsply Sirona, Inc. | 2024-12-17 | Traditional | PDF ↗ |
| K242884 | Additively Manufactured Denture Resin | Aidite (Qinhuangdao) Technology Co., Ltd. | 2024-11-22 | Traditional | PDF ↗ |
| K241089 | KeyPrint KeyDenture Base | Keystone Industries | 2024-10-24 | Traditional | PDF ↗ |
| K241493 | Glidewell 3DP Denture Base Resin | Prismatik Dentalcraft, Inc. | 2024-09-12 | Traditional | PDF ↗ |
| K241071 | NextDent Jet Denture Base; NextDent Jet Denture Teeth | Vertex-Dental B.V. | 2024-09-04 | Traditional | PDF ↗ |
| K240688 | RODIN Titan 3D Resin | Belport Company, Inc., Gingi-Pak | 2024-06-20 | Traditional | PDF ↗ |
| K233859 | BASIS FLOW II | YAMAHACHI DENTAL MFG., Co. | 2024-03-05 | Traditional | PDF ↗ |
| K233995 | Ivotion Base Print | Ivoclar Vivadent, Inc. | 2024-02-23 | Traditional | PDF ↗ |
| K233171 | PF Keep; Cad Cam Keep Block | Clemde SA DE CV | 2023-11-27 | Traditional | PDF ↗ |
| K231388 | NextDent Base | Vertex-Dental B.V. | 2023-10-20 | Abbreviated | PDF ↗ |
| K231578 | Lucitone Digital Print Denture System | Dentsply Sirona | 2023-10-20 | Abbreviated | PDF ↗ |
| K232691 | Polibond | Zirkonzahn Srl | 2023-09-05 | Traditional | PDF ↗ |
| K231389 | Harvest Dental HD Gum Strip | Harvest Dental Products, LLC | 2023-08-16 | Traditional | PDF ↗ |
| K230445 | OnX Tough | Sprintray, Inc. | 2023-07-14 | Traditional | PDF ↗ |
| K230410 | DD medical polymers (PMMA) | Dental Direkt GmbH | 2023-06-23 | Special | PDF ↗ |
| K222489 | Harvest Printable Resin | Harvest Dental Products, LLC | 2023-05-12 | Traditional | PDF ↗ |
| K230098 | Trusana | Myerson, LLC | 2023-04-13 | Traditional | PDF ↗ |
| K230341 | ACRIFIX | Deltamed GmbH | 2023-04-06 | Traditional | PDF ↗ |
| K230115 | Denture Base Resin | Aidite (Qinhuangdao) Technology Co., Ltd. | 2023-03-17 | Traditional | PDF ↗ |
| K220042 | Dentca Base Premium, Dentca Base Hi-Impact | Dentca, Inc. | 2022-11-17 | Traditional | PDF ↗ |
| K221678 | SprintRay High Impact Denture Base | Sprintray, Inc. | 2022-11-10 | Traditional | PDF ↗ |
| K220236 | V-Print dentbase | Voco GmbH | 2022-09-21 | Traditional | PDF ↗ |
| K220979 | SprintRay Denture Base | Sprintray, Inc. | 2022-09-14 | Traditional | PDF ↗ |
| K220680 | Denture Base Polymers | Shandong Huge Dental Material Corporation | 2022-08-12 | Traditional | PDF ↗ |
| K222414 | TERA HARZ DENTURE | Graphy, Inc. | 2022-08-11 | Traditional | PDF ↗ |
| K220771 | Stratasys TrueDent | Stratasys, Ltd. | 2022-07-07 | Traditional | PDF ↗ |
| K220743 | CediTEC | Voco GmbH | 2022-07-05 | Traditional | PDF ↗ |
| K213765 | Glidewell 3DP Denture Base Resin | Prismatik Dentalcraft, Inc. | 2022-06-22 | Traditional | PDF ↗ |
| K213994 | Flexible Block | Shandong Huge Dental Material Corporation | 2022-03-04 | Traditional | PDF ↗ |
| K212541 | 3Delta Denture Base - 3Delta Denture Bond - 3Delta Denture Fix | Deltamed GmbH | 2022-01-10 | Traditional | PDF ↗ |
| K210189 | Pac-Dent Denture Base Resin | Pac-Dent, Inc. | 2021-07-28 | Traditional | PDF ↗ |
| K210298 | GR-14 Resin System | Pro3Dure Medical GmbH | 2021-05-05 | Traditional | PDF ↗ |
| K203641 | E-Denture Pro | Envisiontec GmbH | 2021-03-30 | Traditional | PDF ↗ |
| K210828 | DIOnavi-Denture02 | Dio Corporation | 2021-03-23 | Traditional | PDF ↗ |
| K200580 | FotoDent denture | Dreve Dentamid GmbH | 2020-11-19 | Abbreviated | PDF ↗ |
| K200461 | Freeprint denture | Detax GmbH & Co. KG | 2020-11-16 | Traditional | PDF ↗ |
| K193623 | DIOnavi-Denture | Dio Corporation | 2020-10-22 | Traditional | PDF ↗ |
| K191591 | BB Base 3D printing resin for denture base | Enlighten Materials Co., Ltd. | 2020-08-18 | Traditional | PDF ↗ |
| K190790 | Flex Fit | Dk Mungyo Corporation | 2020-07-31 | Traditional | PDF ↗ |
| K191926 | VITA VIONIC Bond | Vita Zanhnfabrik H. Rauter GmbH Co. | 2020-01-29 | Traditional | PDF ↗ |
| K191497 | NextDent Denture 3D+ | Vertex-Dental B.V. | 2019-11-01 | Abbreviated | PDF ↗ |
| K190940 | Tokuyama Rebase III | Tokuyama Dental Corporation | 2019-10-04 | Traditional | PDF ↗ |
| K191427 | Halley resin system | Dentsply Sirona | 2019-08-26 | Traditional | PDF ↗ |
| K190043 | Halley resin | Dentsply Sirona | 2019-04-24 | Traditional | PDF ↗ |
| K181331 | JUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster White | Juvora, Ltd. | 2018-12-21 | Traditional | PDF ↗ |
| K182422 | Lucitone Denture Base Materials | Dentsply Sirona | 2018-12-18 | Traditional | PDF ↗ |
| K181220 | Juell 3D Volo Base | Park Dental Research Corporation | 2018-10-12 | Traditional | PDF ↗ |
| K172764 | Keymill | Mycone Dental Supply Company, Inc. (Aka Keystone Industries) | 2018-04-27 | Traditional | PDF ↗ |
| K172683 | Yamahachi Pink CAD/CAM Disk | YAMAHACHI DENTAL MFG., Co. | 2018-01-16 | Traditional | PDF ↗ |
| K172407 | Duracetal | The Myerson Company Limited | 2017-11-02 | Traditional | PDF ↗ |
| K170375 | Nobilplast Denture Resin | Cmp Industries, LLC | 2017-10-02 | Traditional | PDF ↗ |
| K170549 | TOKUYAMA CUREGRACE | Tokuyama Dental Corporation | 2017-07-05 | Traditional | PDF ↗ |
| K162572 | NextDent Denture, E-Denture | Vertex-Dental B.V. | 2017-06-30 | Traditional | PDF ↗ |
| K163482 | Orthodontic Acrylic 2 | Lang Dental Manufacturing Co., Inc. | 2017-05-31 | Traditional | PDF ↗ |
| K162654 | mollosil plus | Detax GmbH & Co. KG | 2017-03-13 | Traditional | PDF ↗ |
| K162044 | Dentca Denture Base II | Dentca, Inc. | 2017-03-03 | Traditional | PDF ↗ |
| K160918 | JUVORA Dental Disc, Ceramill PEEK by JUVORA | Juvora | 2017-02-13 | Traditional | PDF ↗ |
| K161330 | Pour Acrylic | Dentsply Sirona | 2016-10-06 | Traditional | PDF ↗ |
| K153546 | PINK CAD/CAM disc | Polident D.O.O., Dental Products Industry | 2016-09-28 | Traditional | PDF ↗ |
| K152981 | JET SET 4 DENTURE REPAIR RESIN | Lang Dental Manufacturing Company, Inc. | 2016-09-02 | Traditional | PDF ↗ |
| K160498 | Dentivera Milling Disc | Dental Solutions, LLC | 2016-06-15 | Traditional | PDF ↗ |
| K153590 | AvaDent Denture Base Material | Global Dental Science | 2016-04-22 | Traditional | PDF ↗ |
| K152051 | ClearMet | Mycone Dental Supply Co., T/A Keystone Industries | 2016-03-22 | Traditional | PDF ↗ |
| K153253 | GC Reline II | GC America, Inc. | 2016-03-03 | Traditional | PDF ↗ |
| K152270 | Denture base resin | Korea Engineering Plastics Co., Ltd. | 2015-11-13 | Traditional | PDF ↗ |
| K151646 | ProTech Plus | Protech Professional Products, Inc. | 2015-10-21 | Special | PDF ↗ |
| K151142 | IVOBASE CAD FOR ZENOTEC, IVOBASE CAD BOND, IVOBASE CAD MODELLING LIQUID | Wieland Dental + Technik GmbH & Co. KG | 2015-08-13 | Traditional | PDF ↗ |
| K143033 | DENTCA DENTURE BASE | Dentca, Inc. | 2015-07-21 | Traditional | PDF ↗ |
| K150511 | Coating Material | Sun Medical Co., Ltd. | 2015-05-27 | Traditional | PDF ↗ |
| K150454 | Acryfree Denture Base Material and Biosens Denture Base Material | Perflex | 2015-05-26 | Traditional | PDF ↗ |
| K143265 | Acrylic Block | Sun Medical Co., Ltd. | 2015-04-14 | Traditional | PDF ↗ |
| K142894 | TCS Blend | Thermoplastic Comfort Systems, Inc. | 2015-02-03 | Traditional | PDF ↗ |
| K143486 | Ufi Gel hard C | Voco GmbH | 2015-01-07 | Special | PDF ↗ |
| K140758 | M-PM-DISC (PINK) | Merz Dental GmbH | 2014-09-15 | Traditional | PDF ↗ |
| K141439 | ORTHODONTIC ACRYLIC (NOT FINALIZED) | Bisco, Inc. | 2014-09-12 | Traditional | PDF ↗ |
| K140570 | CHAIRSIDE ATTACHMENT PROCESSING MATERIAL | Zest Anchors, LLC | 2014-06-16 | Traditional | PDF ↗ |
| K140146 | COMFORTSOFT SOFT DENTURE LINER SYSTEM | Whip Mix Corp. | 2014-04-29 | Traditional | PDF ↗ |
| K132725 | JUVORA DENTQAL DISC | Juvora | 2014-01-23 | Traditional | PDF ↗ |
| K130076 | PROMOLUX, PROMOLUX HI, WEROPRESS, PREMECO PCS | Merz Dental GmbH | 2013-08-22 | Traditional | PDF ↗ |
| K130680 | ACRYTONE, REZEN NF, AND ISO FAST DENTURE RESINS | Dentsoll, Inc. | 2013-07-26 | Traditional | PDF ↗ |
| K131036 | YAMAHACHI DENTURE BASE RESINS | Yamahachi Dental Manufacturing Co. | 2013-07-12 | Traditional | PDF ↗ |
Product code EBI · Class II · Dental. Data: openFDA.