ClearanceBrief
Panels › Dental › Product code EBI · Class 2

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)
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Top companies in EBI

Company510(k)sRecalls
Dentsply Intl.160
Heraeus Kulzer, Inc.130
GC America, Inc.120
Cmp Industries, LLC56
Harry J. Bosworth Co.80
Lang Dental Mfg. Co., Inc.71
Voco GmbH80
Vertex-Dental B.V.70
Dentsply Sirona60
Stick Tech , Ltd.60
Decided510(k)Device and applicantCode
Aug 27, 2026K261802Glidewell™ Denture Base Resin
Prismatik Dentalcraft, Inc.
EBI
Aug 13, 2026K261626UltraPrint Flexible Denture UV
Guangzhou Heygears IMC., Inc., CN
EBI
Jul 31, 2026K262681NanoCeram Resin
3BFAB TEKNOLOJI A.S., TR
EBI
Jul 8, 2026K262300Denture Base Resin V2
Formlabs Ohio, Inc.
EBI
Jul 1, 2026K261474DENTCA Tru Flexible
Dentca, Inc.
EBI
Jun 2, 2026K260569DB 4000 High Impact Denture Base
Carbon, Inc.
EBI
May 6, 2026K260376Denture Base
Shandong Huge Dental Material Corporation, CN
EBI
Nov 25, 2025K253365LuxCreo Flexible Partial Denture Resin
LuxCreo, Inc.
EBI
Nov 21, 2025K253681TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HARZ Hard Denture (THD-LP-500); TERA HARZ
Graphy, Inc., KR
EBI
Nov 20, 2025K253324UltraPrint-Dental Denture UV
Guangzhou Heygears IMC., Inc., CN
EBI
Oct 30, 2025K252430Freeprint® denture flex
Detax GmbH, DE
EBI
Sep 17, 2025K252035DENTURE SOFT EX (Pink set); DENTURE SOFT EX (White set); DENTURE SOFT EX (Pink powder); DENTURE SPFT EX (White powder);
Kamemizu Chemical Industry Co., Ltd., JP
EBI
Jun 25, 2025K250302Flexible Partial Resin
Prismatik Dentalcraft, Inc.
EBI
Jun 3, 2025K242897Partial Flex
Clemde SA DE CV, MX
EBI
May 20, 2025K250489FP3D
Keystone Industries
EBI
Apr 29, 2025K250617Apex Flex
Sprintray, Inc.
EBI
Apr 11, 2025K243356Asiga DentaBASE
Asiga Pty, Ltd., AU
EBI
Mar 31, 2025K250946Denture Base Resin DT20
Hangzhou SHINING3D Dental Technology Co., Ltd., CN
EBI
Dec 23, 2024K243103Denture Base
Riton 3D Technology Co., Ltd., CN
EBI
Dec 17, 2024K243336Lucitone Digital Print Denture™ System
Dentsply Sirona, Inc.
EBI
Nov 22, 2024K242884Additively Manufactured Denture Resin
Aidite (Qinhuangdao) Technology Co., Ltd., CN
EBI
Oct 24, 2024K241089KeyPrint KeyDenture Base
Keystone Industries
EBI
Sep 12, 2024K241493Glidewell™ 3DP Denture Base Resin
Prismatik Dentalcraft, Inc.
EBI
Sep 4, 2024K241071NextDent Jet Denture Base; NextDent Jet Denture Teeth
Vertex-Dental B.V., NL
EBI
Jun 20, 2024K240688RODIN Titan 3D Resin
Belport Company, Inc., Gingi-Pak
EBI
Mar 5, 2024K233859BASIS FLOW II
YAMAHACHI DENTAL MFG., Co., JP
EBI
Feb 23, 2024K233995Ivotion Base Print
Ivoclar Vivadent, Inc.
EBI
Nov 27, 2023K233171PF Keep; Cad Cam Keep Block
Clemde SA DE CV, MX
EBI
Oct 20, 2023K231578Lucitone Digital Print Denture System
Dentsply Sirona
EBI
Oct 20, 2023K231388NextDent Base
Vertex-Dental B.V., NL
EBI
Sep 5, 2023K232691Polibond
Zirkonzahn Srl, IT
EBI
Aug 16, 2023K231389Harvest Dental HD Gum Strip
Harvest Dental Products, LLC
EBI
Jul 14, 2023K230445OnX Tough
Sprintray, Inc.
EBI
Jun 23, 2023K230410DD medical polymers (PMMA)
Dental Direkt GmbH, DE
EBI
May 12, 2023K222489Harvest Printable Resin
Harvest Dental Products, LLC
EBI
Apr 13, 2023K230098Trusana™
Myerson, LLC
EBI
Apr 6, 2023K230341ACRIFIX
Deltamed GmbH, DE
EBI
Mar 17, 2023K230115Denture Base Resin
Aidite (Qinhuangdao) Technology Co., Ltd., CN
EBI
Nov 17, 2022K220042Dentca Base Premium, Dentca Base Hi-Impact
Dentca, Inc.
EBI
Nov 10, 2022K221678SprintRay High Impact Denture Base
Sprintray, Inc.
EBI
Sep 21, 2022K220236V-Print dentbase
Voco GmbH, DE
EBI
Sep 14, 2022K220979SprintRay Denture Base
Sprintray, Inc.
EBI
Aug 12, 2022K220680Denture Base Polymers
Shandong Huge Dental Material Corporation, CN
EBI
Aug 11, 2022K222414TERA HARZ DENTURE
Graphy, Inc., KR
EBI
Jul 7, 2022K220771Stratasys TrueDent
Stratasys, Ltd., IL
EBI
Jul 5, 2022K220743CediTEC
Voco GmbH, DE
EBI
Jun 22, 2022K213765Glidewell 3DP Denture Base Resin
Prismatik Dentalcraft, Inc.
EBI
Mar 4, 2022K213994Flexible Block
Shandong Huge Dental Material Corporation, CN
EBI
Jan 10, 2022K2125413Delta Denture Base - 3Delta Denture Bond - 3Delta Denture Fix
Deltamed GmbH, DE
EBI
Jul 28, 2021K210189Pac-Dent Denture Base Resin
Pac-Dent, Inc.
EBI

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