Atlas FDA

EBI

333 FDA 510(k) clearances · Product code

85 daysmedian time to decision
203 days90th percentile
333clearances measured

FDA profile

Official device name
Resin, Denture, Relining, Repairing, Rebasing
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3760
Medical specialty
Dental
Flags
Third-party review eligible
Adverse events (MAUDE)
2012: 9 · 2014: 9 · 2015: 8 · 2016: 9 · 2021: 25 · 2025: 35
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
NanoCeram Resin (K262681)3BFAB TEKNOLOJI A.S.2026-07-31
Denture Base Resin V2 (K262300)Formlabs Ohio, Inc.2026-07-08
DENTCA Tru Flexible (K261474)Dentca, Inc.2026-07-01
DB 4000 High Impact Denture Base (K260569)Carbon, Inc.2026-06-02
Denture Base (K260376)Shandong Huge Dental Material Corporation2026-05-06
LuxCreo Flexible Partial Denture Resin (K253365)LuxCreo, Inc.2025-11-25
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) (K253681)Graphy, Inc.2025-11-21
UltraPrint-Dental Denture UV (K253324)Guangzhou Heygears IMC., Inc.2025-11-20
Freeprint® denture flex (K252430)Detax GmbH2025-10-30
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) (K252035)Kamemizu Chemical Industry Co., Ltd.2025-09-17
Flexible Partial Resin (K250302)Prismatik Dentalcraft, Inc.2025-06-25
Partial Flex (K242897)Clemde SA DE CV2025-06-03
FP3D (K250489)Keystone Industries2025-05-20
Apex Flex (K250617)Sprintray, Inc.2025-04-29
Asiga DentaBASE (K243356)Asiga Pty, Ltd.2025-04-11
Denture Base Resin DT20 (K250946)Hangzhou SHINING3D Dental Technology Co., Ltd.2025-03-31
Denture Base (K243103)Riton 3D Technology Co., Ltd.2024-12-23
Lucitone Digital Print Denture™ System (K243336)Dentsply Sirona, Inc.2024-12-17
Additively Manufactured Denture Resin (K242884)Aidite (Qinhuangdao) Technology Co., Ltd.2024-11-22
KeyPrint KeyDenture Base (K241089)Keystone Industries2024-10-24
Glidewell™ 3DP Denture Base Resin (K241493)Prismatik Dentalcraft, Inc.2024-09-12
NextDent Jet Denture Base; NextDent Jet Denture Teeth (K241071)Vertex-Dental B.V.2024-09-04
RODIN Titan 3D Resin (K240688)Belport Company, Inc., Gingi-Pak2024-06-20
BASIS FLOW II (K233859)YAMAHACHI DENTAL MFG., Co.2024-03-05
Ivotion Base Print (K233995)Ivoclar Vivadent, Inc.2024-02-23
PF Keep; Cad Cam Keep Block (K233171)Clemde SA DE CV2023-11-27
Lucitone Digital Print Denture System (K231578)Dentsply Sirona2023-10-20
NextDent Base (K231388)Vertex-Dental B.V.2023-10-20
Polibond (K232691)Zirkonzahn Srl2023-09-05
Harvest Dental HD Gum Strip (K231389)Harvest Dental Products, LLC2023-08-16
OnX Tough (K230445)Sprintray, Inc.2023-07-14
DD medical polymers (PMMA) (K230410)Dental Direkt GmbH2023-06-23
Harvest Printable Resin (K222489)Harvest Dental Products, LLC2023-05-12
Trusana™ (K230098)Myerson, LLC2023-04-13
ACRIFIX (K230341)Deltamed GmbH2023-04-06
Denture Base Resin (K230115)Aidite (Qinhuangdao) Technology Co., Ltd.2023-03-17
Dentca Base Premium, Dentca Base Hi-Impact (K220042)Dentca, Inc.2022-11-17
SprintRay High Impact Denture Base (K221678)Sprintray, Inc.2022-11-10
V-Print dentbase (K220236)Voco GmbH2022-09-21
SprintRay Denture Base (K220979)Sprintray, Inc.2022-09-14
Denture Base Polymers (K220680)Shandong Huge Dental Material Corporation2022-08-12
TERA HARZ DENTURE (K222414)Graphy, Inc.2022-08-11
Stratasys TrueDent (K220771)Stratasys, Ltd.2022-07-07
CediTEC (K220743)Voco GmbH2022-07-05
Glidewell 3DP Denture Base Resin (K213765)Prismatik Dentalcraft, Inc.2022-06-22
Flexible Block (K213994)Shandong Huge Dental Material Corporation2022-03-04
3Delta Denture Base - 3Delta Denture Bond - 3Delta Denture Fix (K212541)Deltamed GmbH2022-01-10
Pac-Dent Denture Base Resin (K210189)Pac-Dent, Inc.2021-07-28
GR-14 Resin System (K210298)Pro3Dure Medical GmbH2021-05-05
E-Denture Pro (K203641)Envisiontec GmbH2021-03-30
DIOnavi-Denture02 (K210828)Dio Corporation2021-03-23
FotoDent denture (K200580)Dreve Dentamid GmbH2020-11-19
Freeprint denture (K200461)Detax GmbH & Co. KG2020-11-16
DIOnavi-Denture (K193623)Dio Corporation2020-10-22
BB Base 3D printing resin for denture base (K191591)Enlighten Materials Co., Ltd.2020-08-18
Flex Fit (K190790)Dk Mungyo Corporation2020-07-31
VITA VIONIC Bond (K191926)Vita Zanhnfabrik H. Rauter GmbH Co.2020-01-29
NextDent Denture 3D+ (K191497)Vertex-Dental B.V.2019-11-01
Tokuyama Rebase III (K190940)Tokuyama Dental Corporation2019-10-04
Halley resin system (K191427)Dentsply Sirona2019-08-26
Halley resin (K190043)Dentsply Sirona2019-04-24
JUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster White (K181331)Juvora, Ltd.2018-12-21
Lucitone Denture Base Materials (K182422)Dentsply Sirona2018-12-18
Juell 3D Volo Base (K181220)Park Dental Research Corporation2018-10-12
Keymill (K172764)Mycone Dental Supply Company, Inc. (Aka Keystone Industries)2018-04-27
Yamahachi Pink CAD/CAM Disk (K172683)YAMAHACHI DENTAL MFG., Co.2018-01-16
Duracetal (K172407)The Myerson Company Limited2017-11-02
Nobilplast Denture Resin (K170375)Cmp Industries, LLC2017-10-02
TOKUYAMA CUREGRACE (K170549)Tokuyama Dental Corporation2017-07-05
NextDent Denture, E-Denture (K162572)Vertex-Dental B.V.2017-06-30
Orthodontic Acrylic 2 (K163482)Lang Dental Manufacturing Co., Inc.2017-05-31
mollosil plus (K162654)Detax GmbH & Co. KG2017-03-13
Dentca Denture Base II (K162044)Dentca, Inc.2017-03-03
JUVORA Dental Disc, Ceramill PEEK by JUVORA (K160918)Juvora2017-02-13
Pour Acrylic (K161330)Dentsply Sirona2016-10-06
PINK CAD/CAM disc (K153546)Polident D.O.O., Dental Products Industry2016-09-28
JET SET 4 DENTURE REPAIR RESIN (K152981)Lang Dental Manufacturing Company, Inc.2016-09-02
Dentivera Milling Disc (K160498)Dental Solutions, LLC2016-06-15
AvaDent Denture Base Material (K153590)Global Dental Science2016-04-22
ClearMet (K152051)Mycone Dental Supply Co., T/A Keystone Industries2016-03-22
GC Reline II (K153253)GC America, Inc.2016-03-03
Denture base resin (K152270)Korea Engineering Plastics Co., Ltd.2015-11-13
ProTech Plus (K151646)Protech Professional Products, Inc.2015-10-21
IVOBASE CAD FOR ZENOTEC, IVOBASE CAD BOND, IVOBASE CAD MODELLING LIQUID (K151142)Wieland Dental + Technik GmbH & Co. KG2015-08-13
DENTCA DENTURE BASE (K143033)Dentca, Inc.2015-07-21
Coating Material (K150511)Sun Medical Co., Ltd.2015-05-27
Acryfree Denture Base Material and Biosens Denture Base Material (K150454)Perflex2015-05-26
Acrylic Block (K143265)Sun Medical Co., Ltd.2015-04-14
TCS Blend (K142894)Thermoplastic Comfort Systems, Inc.2015-02-03
Ufi Gel hard C (K143486)Voco GmbH2015-01-07
M-PM-DISC (PINK) (K140758)Merz Dental GmbH2014-09-15
ORTHODONTIC ACRYLIC (NOT FINALIZED) (K141439)Bisco, Inc.2014-09-12
CHAIRSIDE ATTACHMENT PROCESSING MATERIAL (K140570)Zest Anchors, LLC2014-06-16
COMFORTSOFT SOFT DENTURE LINER SYSTEM (K140146)Whip Mix Corp.2014-04-29
JUVORA DENTQAL DISC (K132725)Juvora2014-01-23
PROMOLUX, PROMOLUX HI, WEROPRESS, PREMECO PCS (K130076)Merz Dental GmbH2013-08-22
ACRYTONE, REZEN NF, AND ISO FAST DENTURE RESINS (K130680)Dentsoll, Inc.2013-07-26
YAMAHACHI DENTURE BASE RESINS (K131036)Yamahachi Dental Manufacturing Co.2013-07-12
VERTEX THERMOSENS RIGID (K123220)Vertex-Dental B.V.2013-03-01
I.FLEX BY TCS (K123396)Thermoplastic Comfort Systems, Inc.2013-01-10
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