Atlas FDA

ELW

402 FDA 510(k) clearances · Product code

70 daysmedian time to decision
191 days90th percentile
402clearances measured

FDA profile

Official device name
Material, Impression
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3660
Medical specialty
Dental
Flags
Third-party review eligible
Adverse events (MAUDE)
2015: 18 · 2016: 15 · 2017: 17 · 2018: 14 · 2019: 24 · 2025: 24
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Dia-X Sil Bite (K254112)DiaDent Group International2026-03-19
Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set - 454g (1lb) (052327); Chroma Print Premium Fast Set - 454g (1lb) (052457); Chroma Print Premium Regular Set - 454g (1lb) (051460); Perfil Pro - 454g (1lb) (056213); Perfil Pro+ - 454g (1lb) (056121); Perfil Pro Chroma - 454g (1lb) (056122); Hydro Print Premium Fast Set - Multi Pack (056205); Hydro Print Premium Regular Set - Multi Pack (056208); Hydro Print Premium Fast Set - 9,07Kg (20lb) (056204); (K253501)Vigodent Indústria E Comercio Ltda2025-10-31
JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST (K250969)Dent4you AG2025-06-27
Elastic Impression Material (K241924)Beijing Okvd Biological Technology , Ltd.2024-12-27
Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator (K242360)Dent4you AG2024-11-15
Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu (K233954)B&E Korea Co., Ltd.2024-02-13
DentMix VPS Impression Material (K223892)Innovative Product Brands, Inc.2023-04-27
No Stress Impress (K213175)No Stress Impress, LLC2023-01-19
Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty (K214086)Genoss Co., Ltd.2022-12-15
DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast) (K222741)Hdi, Inc.2022-11-07
Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration) (K213244)Prevest Denpro Limited2022-09-09
Dental Impression Material (K221668)Chemoment Materials Co.,Ltd2022-08-08
IMICRYL Impression Materials (K213890)Imicryl Dis Malzemeleri San. VE Tic. A.S.2022-02-11
Permadyne (K220257)3M Deutschland GmbH2022-02-01
PRESIDENT The Original (K220097)Coltène/Whaledent AG2022-01-13
Dental Impression Material (K211489)Nanchang Dental Bright Technology Co., Ltd.2021-07-28
VPS Impression Material (K203824)Hygedent, Inc.2021-04-19
HySil Plus Impression Materials (K210041)Osstem Implant Co., Ltd.2021-03-18
Impression Material (K201483)Zhengzhou Huaer Electro Optics Technology Co., Ltd.2020-10-08
A-Silicone for Bite Registration (K201684)Shandong Huge Dental Material Corporation2020-09-24
Lascod Impression Materials (K201184)Lascod Spa2020-05-05
HySil Super Fast Impression Materials (K192941)Osstem Implant Co., Ltd.2020-01-30
StoneBite and StoneBite scan (K190571)Dreve Dentamid GmbH2019-11-07
VPS Impression Material (K191034)Hygedent, Inc.2019-09-04
Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite (K181604)Hrs Co., Ltd.2018-11-28
HySil Impression Materials (K181236)Osstem Implant Co., Ltd.2018-09-13
AIM2 (K181011)GC America, Inc.2018-07-12
PEAK NS033CF, PEAK NS017CF (K180565)Neosil Co., Ltd.2018-06-13
Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono (K171562)Dreve Dentamid GmbH2018-04-13
Rapid HB, Rapid LB, Rapid MB (K173318)3M Deutschland GmbH2017-10-31
HygePLUS Alginate Impression Material (K170812)Hygedent, Inc.2017-07-26
HySil Impression Materials (K170736)Osstem Implant Co., Ltd.2017-06-07
Vonflex S (K152615)Vericom Co., Ltd.2016-11-03
i-Sil (K161774)Spident Co., Ltd.2016-09-30
Image Fast Set, Image Regular Set (K160097)Sybron Dental Specialties2016-08-05
Identic and KromaFaze Alginate Dental Impression Materials (K160441)Kerr Corporation2016-06-30
NoCord (K152826)Centrix, Inc.2016-05-27
CharmFlex (K152766)Dentkist, Inc.2016-03-08
Aquasil Ultra + Smart Wetting Impression Material (K152861)Dentply International, Inc.2016-03-04
Vonflex S Putty (K152518)Vericom Co., Ltd.2015-11-30
Star+ VPS Scannable Impression Material (K152349)Danville Materials, LLC2015-11-23
Cavex Cream Alginate (K151535)Cavex Holland BV2015-10-28
PEAK (K152180)Neosil Co., Ltd.2015-10-22
Hyflex Heavy, Hyflex Mono, Hyflex Light (K151262)Osstem Implant Co., Ltd.2015-09-21
Elements (K151150)Pac-Dent International, Inc.2015-07-28
Accu-Dent XD Tray, Accu-Dent XD Syringe (K143575)Ivoclar Vivadent, Inc.2015-04-03
DentiAnn Smart Sil (K143382)Seilglobal Co., Ltd.2015-02-23
MARK3 (K141092)Cavex Holland BV2014-12-04
VONFLEX S BITE (K140966)Vericom Co., Ltd.2014-08-15
SILDENT (K132869)Hrs Co., Ltd.2014-06-19
FLASH PENTA MB QUICK, FLASH MB QUICK (K140602)3M Espe AG2014-06-05
ELASTIC IMPRESSION MATERIAL (K133071)Rizhao Huge Dental Industry Co., Ltd.2014-05-28
HYGEDENT ALGINATE IMPRESSION MATERIAL (K140074)Hygedent, Inc.2014-05-21
MD-FLEX HEAVY BODY (K134008)Meta Biomed, Inc.2014-04-09
SUFLEX PUTTY, SUFLEX HEAVY, SUFLEX MONO, SUFLEX LIGHT (K133527)Osstem Germany GmbH2014-03-07
FLASH AR; FLASH AR QUICK (K133436)3M Deutschland GmbH2014-03-07
FLASH BITE (K133400)3M Espe AG2014-03-06
SMILEBOND SYSTEM (K132599)Millennium Company, LLC2014-02-25
POLYDIMETHYLSILOXANE IMPRESSION MATERIAL (K131510)Blackwell Device Consulting2013-12-20
CORRECT PLUS 1 (K130920)Pentron Clinical2013-07-02
TAKE 1 ADVANCE (K130869)Sybron Dental Specialties2013-05-30
FLASH AR PENTA / FLASH AR PENTA QUICK (K131404)3M Deutschland GmbH2013-05-30
XANTASIL DYNAMIX FAST SET CARTRIDGE -2 X 380ML; XANTASIL FAST SET CARTRIDGE -6 X 50ML (K130647)Heraeus Kulzer, LLC2013-05-17
ALGINOR ALGINELLE TYPE 1 AND 2 MILLENIUM KROMOPAN 1 AND 2 (K121824)Lascod Spa2012-08-23
FLEXITIME FAST & SCAN LIGHT FLOW (K120914)Heraeus Kulzer, LLC2012-07-25
FLEXITIME MONOPHASE PRO SCAN (K113574)Heraeus Kulzer, LLC2012-07-13
TEMPSPAN CLEAR MATRIX (K120013)Pentron Clinical2012-05-22
GC BLUE SILICONE (K120521)GC America, Inc.2012-05-10
FLASH (DIFFERENT MATERIALS) (K120438)3M Deutschland GmbH2012-05-02
AQUASIL ULTRA SMART WETTING IMPRESSION MATERIAL (K113406)Dentsply International, Inc.2012-02-13
IDENTIUM HEAVY, IDENTIUM MEDIUM, IDENTIUM SCAN HEAVY, IDENTIUM SCAN MEDIUM, IDENTIUM SCAN LIGHT (K113279)Kettenbach GmbH & Co. KG2011-11-14
ARGES IMAGING CONTRAST SPRAY (K113263)Arges Imaging, Inc.2011-11-14
FIT CHECKER ADVANCED (K110871)GC America, Inc.2011-06-17
TAKE 1 ADVANCED RIGID TRAY (K110092)Kerr Corporation2011-04-08
IMPRESSION COMPOUND (K110378)Spofadental2011-04-05
IOS FASTSCAN SPRAY (K103586)Ios Technnologies, Inc.2011-03-30
FIT TEST C&B (K110050)Voco GmbH2011-03-28
DELIKIT PUTTY, DELIKIT HEAVY BODY, DELIKIT LIGHT BODY (K103346)Sherpa Korea2011-02-11
BONASIL A+ IMPRESSION MATERIALS (K102836)Dmp, Ltd.2011-01-13
FLEXTIME FAST & SCAN PUTTY, FLEXTIME FAST & SCAN LIGHT FLOW, FLEXTIME FAST & SCAN MEDIUM FLOW (K102770)Heraeus Kulzer, LLC2010-12-21
HYDROCOLOR 5 (K102739)Cascades Device Consulting Associates2010-12-08
VONFLEX HEAVY, VINFLEX LIGHT (K103164)Vericom Co., Ltd.2010-11-10
FLEXITIME XTREME 2 HEAVY TRAY CARTRIDGE REFILL, FEXITIME XTREME 2 LIGHT TRAY CARTRIDGE REFILL (K101617)Heraeus Kulzer, LLC2010-09-07
TAKE 1 ADVANCED RIGID TRAY (K092176)Kerr Corporation2010-01-28
TAKE 1 (K091613)Kerr Corp.2009-10-07
IDENTIUM HEAVY, MEDIUM, MEDIUM SOFT, LIGHT (K092867)Kettenbach GmbH & Co. KG2009-10-01
STAR VPS, MODEL 80014-01, FIRST QUATER, MODEL 90649, FIRST HALF, MODEL 89387 (K092319)Danville Materials, Inc.2009-09-16
FLEXITIME FLOW (K091494)Heraeus Kulzer, Inc.2009-07-31
VONFLEX PUTTY (K091267)Vericom Co., Ltd.2009-05-06
HYDRORISE AND HYDROSYSTEM (K083739)Zhermack S.P.A.2009-03-26
PANASIL INITIAL CONTACT AND PANASIL TRAY (K083701)Kettenbach GmbH & Co. KG2009-01-09
FLEXITIME BITE (K082591)Heraeus Kulzer, Inc., Dental Products Division2008-12-05
PANASIL IMPRESSION MATERIALS, INCLUDING PUTTY, BINETICS, TRAY, MONOPHASE AND CONTACT (K082560)Kettenbach GmbH & Co. KG2008-09-08
KETTOSIL AND SILGINAT (K082157)Kettenbach GmbH & Co. KG2008-08-06
TEMPLATE AND COUNTER-FIT (K081017)Clinician'S Choice Dental Products, Inc.2008-08-04
COLORISE RIGID (K081084)Zhermack S.P.A.2008-05-14
FUTAR (FUTAR, FUTAR D, FUTAR D FAST, FUTAR D SLOW, FUTAR SCAN BITE REGISTRATION MATERIALS (K081120)Kettenbach GmbH & Co. KG2008-05-01
CUTTERSIL ACTIVATOR UNIVERSAL PLUS (K080338)Heraeus Kulzer,GmbH2008-04-21
CEREC OPTI SPRAY (K080882)Sirona Dental Systems GmbH2008-04-11
PECD-01 AND PECD QUICK-01 (K080514)3M Espe AG Dental Products2008-03-26
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