FDA Product Code
FDA Product Code ELW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.3660
510(k) Clearances — 404 records · page 1 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K254152 | Dia-X Sil Light Body | DiaDent Group International | 2026-09-16 | Traditional | PDF ↗ |
| K254142 | Dia-X Sil Heavy Body | DiaDent Group International | 2026-09-16 | Traditional | PDF ↗ |
| K254112 | Dia-X Sil Bite | DiaDent Group International | 2026-03-19 | Traditional | PDF ↗ |
| K253501 | 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); | Vigodent Indústria E Comercio Ltda | 2025-10-31 | Traditional | PDF ↗ |
| K250969 | JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST | Dent4you AG | 2025-06-27 | Abbreviated | PDF ↗ |
| K241924 | Elastic Impression Material | Beijing Okvd Biological Technology , Ltd. | 2024-12-27 | Abbreviated | PDF ↗ |
| K242360 | Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator | Dent4you AG | 2024-11-15 | Traditional | PDF ↗ |
| K233954 | Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu | B&E Korea Co., Ltd. | 2024-02-13 | Traditional | PDF ↗ |
| K223892 | DentMix VPS Impression Material | Innovative Product Brands, Inc. | 2023-04-27 | Traditional | PDF ↗ |
| K213175 | No Stress Impress | No Stress Impress, LLC | 2023-01-19 | Traditional | PDF ↗ |
| K214086 | Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty | Genoss Co., Ltd. | 2022-12-15 | Traditional | PDF ↗ |
| K222741 | DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast) | Hdi, Inc. | 2022-11-07 | Traditional | PDF ↗ |
| K213244 | 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) | Prevest Denpro Limited | 2022-09-09 | Traditional | PDF ↗ |
| K221668 | Dental Impression Material | Chemoment Materials Co.,Ltd | 2022-08-08 | Traditional | PDF ↗ |
| K213890 | IMICRYL Impression Materials | Imicryl Dis Malzemeleri San. VE Tic. A.S. | 2022-02-11 | Traditional | PDF ↗ |
| K220257 | Permadyne | 3M Deutschland GmbH | 2022-02-01 | Traditional | PDF ↗ |
| K220097 | PRESIDENT The Original | Coltène/Whaledent AG | 2022-01-13 | Traditional | PDF ↗ |
| K211489 | Dental Impression Material | Nanchang Dental Bright Technology Co., Ltd. | 2021-07-28 | Traditional | PDF ↗ |
| K203824 | VPS Impression Material | Hygedent, Inc. | 2021-04-19 | Traditional | PDF ↗ |
| K210041 | HySil Plus Impression Materials | Osstem Implant Co., Ltd. | 2021-03-18 | Traditional | PDF ↗ |
| K201483 | Impression Material | Zhengzhou Huaer Electro Optics Technology Co., Ltd. | 2020-10-08 | Traditional | PDF ↗ |
| K201684 | A-Silicone for Bite Registration | Shandong Huge Dental Material Corporation | 2020-09-24 | Traditional | PDF ↗ |
| K201184 | Lascod Impression Materials | Lascod Spa | 2020-05-05 | Traditional | PDF ↗ |
| K192941 | HySil Super Fast Impression Materials | Osstem Implant Co., Ltd. | 2020-01-30 | Traditional | PDF ↗ |
| K190571 | StoneBite and StoneBite scan | Dreve Dentamid GmbH | 2019-11-07 | Abbreviated | PDF ↗ |
| K191034 | VPS Impression Material | Hygedent, Inc. | 2019-09-04 | Traditional | PDF ↗ |
| K181604 | Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite | Hrs Co., Ltd. | 2018-11-28 | Traditional | PDF ↗ |
| K181236 | HySil Impression Materials | Osstem Implant Co., Ltd. | 2018-09-13 | Traditional | PDF ↗ |
| K181011 | AIM2 | GC America, Inc. | 2018-07-12 | Traditional | PDF ↗ |
| K180565 | PEAK NS033CF, PEAK NS017CF | Neosil Co., Ltd. | 2018-06-13 | Traditional | PDF ↗ |
| K171562 | Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono | Dreve Dentamid GmbH | 2018-04-13 | Abbreviated | PDF ↗ |
| K173318 | Rapid HB, Rapid LB, Rapid MB | 3M Deutschland GmbH | 2017-10-31 | Traditional | PDF ↗ |
| K170812 | HygePLUS Alginate Impression Material | Hygedent, Inc. | 2017-07-26 | Traditional | PDF ↗ |
| K170736 | HySil Impression Materials | Osstem Implant Co., Ltd. | 2017-06-07 | Traditional | PDF ↗ |
| K152615 | Vonflex S | Vericom Co., Ltd. | 2016-11-03 | Traditional | PDF ↗ |
| K161774 | i-Sil | Spident Co., Ltd. | 2016-09-30 | Traditional | PDF ↗ |
| K160097 | Image Fast Set, Image Regular Set | Sybron Dental Specialties | 2016-08-05 | Traditional | PDF ↗ |
| K160441 | Identic and KromaFaze Alginate Dental Impression Materials | Kerr Corporation | 2016-06-30 | Traditional | PDF ↗ |
| K152826 | NoCord | Centrix, Inc. | 2016-05-27 | Traditional | PDF ↗ |
| K152766 | CharmFlex | Dentkist, Inc. | 2016-03-08 | Traditional | PDF ↗ |
| K152861 | Aquasil Ultra + Smart Wetting Impression Material | Dentply International, Inc. | 2016-03-04 | Special | PDF ↗ |
| K152518 | Vonflex S Putty | Vericom Co., Ltd. | 2015-11-30 | Traditional | PDF ↗ |
| K152349 | Star+ VPS Scannable Impression Material | Danville Materials, LLC | 2015-11-23 | Traditional | PDF ↗ |
| K151535 | Cavex Cream Alginate | Cavex Holland BV | 2015-10-28 | Traditional | PDF ↗ |
| K152180 | PEAK | Neosil Co., Ltd. | 2015-10-22 | Traditional | PDF ↗ |
| K151262 | Hyflex Heavy, Hyflex Mono, Hyflex Light | Osstem Implant Co., Ltd. | 2015-09-21 | Traditional | PDF ↗ |
| K151150 | Elements | Pac-Dent International, Inc. | 2015-07-28 | Traditional | PDF ↗ |
| K143575 | Accu-Dent XD Tray, Accu-Dent XD Syringe | Ivoclar Vivadent, Inc. | 2015-04-03 | Abbreviated | PDF ↗ |
| K143382 | DentiAnn Smart Sil | Seilglobal Co., Ltd. | 2015-02-23 | Traditional | PDF ↗ |
| K141092 | MARK3 | Cavex Holland BV | 2014-12-04 | Traditional | PDF ↗ |
| K140966 | VONFLEX S BITE | Vericom Co., Ltd. | 2014-08-15 | Traditional | PDF ↗ |
| K132869 | SILDENT | Hrs Co., Ltd. | 2014-06-19 | Traditional | PDF ↗ |
| K140602 | FLASH PENTA MB QUICK, FLASH MB QUICK | 3M Espe AG | 2014-06-05 | Traditional | PDF ↗ |
| K133071 | ELASTIC IMPRESSION MATERIAL | Rizhao Huge Dental Industry Co., Ltd. | 2014-05-28 | Traditional | PDF ↗ |
| K140074 | HYGEDENT ALGINATE IMPRESSION MATERIAL | Hygedent, Inc. | 2014-05-21 | Traditional | PDF ↗ |
| K134008 | MD-FLEX HEAVY BODY | Meta Biomed, Inc. | 2014-04-09 | Traditional | PDF ↗ |
| K133436 | FLASH AR; FLASH AR QUICK | 3M Deutschland GmbH | 2014-03-07 | Traditional | PDF ↗ |
| K133527 | SUFLEX PUTTY, SUFLEX HEAVY, SUFLEX MONO, SUFLEX LIGHT | Osstem Germany GmbH | 2014-03-07 | Traditional | PDF ↗ |
| K133400 | FLASH BITE | 3M Espe AG | 2014-03-06 | Traditional | PDF ↗ |
| K132599 | SMILEBOND SYSTEM | Millennium Company, LLC | 2014-02-25 | Traditional | PDF ↗ |
| K131510 | POLYDIMETHYLSILOXANE IMPRESSION MATERIAL | Blackwell Device Consulting | 2013-12-20 | Traditional | PDF ↗ |
| K130920 | CORRECT PLUS 1 | Pentron Clinical | 2013-07-02 | Traditional | PDF ↗ |
| K131404 | FLASH AR PENTA / FLASH AR PENTA QUICK | 3M Deutschland GmbH | 2013-05-30 | Traditional | PDF ↗ |
| K130869 | TAKE 1 ADVANCE | Sybron Dental Specialties | 2013-05-30 | Traditional | PDF ↗ |
| K130647 | XANTASIL DYNAMIX FAST SET CARTRIDGE -2 X 380ML; XANTASIL FAST SET CARTRIDGE -6 X 50ML | Heraeus Kulzer, LLC | 2013-05-17 | Traditional | PDF ↗ |
| K121824 | ALGINOR ALGINELLE TYPE 1 AND 2 MILLENIUM KROMOPAN 1 AND 2 | Lascod Spa | 2012-08-23 | Traditional | PDF ↗ |
| K120914 | FLEXITIME FAST & SCAN LIGHT FLOW | Heraeus Kulzer, LLC | 2012-07-25 | Special | PDF ↗ |
| K113574 | FLEXITIME MONOPHASE PRO SCAN | Heraeus Kulzer, LLC | 2012-07-13 | Traditional | PDF ↗ |
| K120013 | TEMPSPAN CLEAR MATRIX | Pentron Clinical | 2012-05-22 | Traditional | PDF ↗ |
| K120521 | GC BLUE SILICONE | GC America, Inc. | 2012-05-10 | Traditional | PDF ↗ |
| K120438 | FLASH (DIFFERENT MATERIALS) | 3M Deutschland GmbH | 2012-05-02 | Traditional | PDF ↗ |
| K113406 | AQUASIL ULTRA SMART WETTING IMPRESSION MATERIAL | Dentsply International, Inc. | 2012-02-13 | Traditional | PDF ↗ |
| K113263 | ARGES IMAGING CONTRAST SPRAY | Arges Imaging, Inc. | 2011-11-14 | Traditional | PDF ↗ |
| K113279 | IDENTIUM HEAVY, IDENTIUM MEDIUM, IDENTIUM SCAN HEAVY, IDENTIUM SCAN MEDIUM, IDENTIUM SCAN LIGHT | Kettenbach GmbH & Co. KG | 2011-11-14 | Special | PDF ↗ |
| K110871 | FIT CHECKER ADVANCED | GC America, Inc. | 2011-06-17 | Traditional | PDF ↗ |
| K110092 | TAKE 1 ADVANCED RIGID TRAY | Kerr Corporation | 2011-04-08 | Traditional | PDF ↗ |
| K110378 | IMPRESSION COMPOUND | Spofadental | 2011-04-05 | Traditional | PDF ↗ |
| K103586 | IOS FASTSCAN SPRAY | Ios Technnologies, Inc. | 2011-03-30 | Traditional | PDF ↗ |
| K110050 | FIT TEST C&B | Voco GmbH | 2011-03-28 | Traditional | PDF ↗ |
| K103346 | DELIKIT PUTTY, DELIKIT HEAVY BODY, DELIKIT LIGHT BODY | Sherpa Korea | 2011-02-11 | Traditional | PDF ↗ |
| K102836 | BONASIL A+ IMPRESSION MATERIALS | Dmp, Ltd. | 2011-01-13 | Traditional | PDF ↗ |
| K102770 | FLEXTIME FAST & SCAN PUTTY, FLEXTIME FAST & SCAN LIGHT FLOW, FLEXTIME FAST & SCAN MEDIUM FLOW | Heraeus Kulzer, LLC | 2010-12-21 | Traditional | PDF ↗ |
| K102739 | HYDROCOLOR 5 | Cascades Device Consulting Associates | 2010-12-08 | Traditional | PDF ↗ |
| K103164 | VONFLEX HEAVY, VINFLEX LIGHT | Vericom Co., Ltd. | 2010-11-10 | Traditional | PDF ↗ |
| K101617 | FLEXITIME XTREME 2 HEAVY TRAY CARTRIDGE REFILL, FEXITIME XTREME 2 LIGHT TRAY CARTRIDGE REFILL | Heraeus Kulzer, LLC | 2010-09-07 | Traditional | PDF ↗ |
| K092176 | TAKE 1 ADVANCED RIGID TRAY | Kerr Corporation | 2010-01-28 | Traditional | PDF ↗ |
| K091613 | TAKE 1 | Kerr Corp. | 2009-10-07 | Traditional | PDF ↗ |
| K092867 | IDENTIUM HEAVY, MEDIUM, MEDIUM SOFT, LIGHT | Kettenbach GmbH & Co. KG | 2009-10-01 | Traditional | PDF ↗ |
| K092319 | STAR VPS, MODEL 80014-01, FIRST QUATER, MODEL 90649, FIRST HALF, MODEL 89387 | Danville Materials, Inc. | 2009-09-16 | Traditional | PDF ↗ |
| K091494 | FLEXITIME FLOW | Heraeus Kulzer, Inc. | 2009-07-31 | Traditional | PDF ↗ |
| K091267 | VONFLEX PUTTY | Vericom Co., Ltd. | 2009-05-06 | Traditional | PDF ↗ |
| K083739 | HYDRORISE AND HYDROSYSTEM | Zhermack S.P.A. | 2009-03-26 | Traditional | PDF ↗ |
| K083701 | PANASIL INITIAL CONTACT AND PANASIL TRAY | Kettenbach GmbH & Co. KG | 2009-01-09 | Special | PDF ↗ |
| K082591 | FLEXITIME BITE | Heraeus Kulzer, Inc., Dental Products Division | 2008-12-05 | Traditional | PDF ↗ |
| K082560 | PANASIL IMPRESSION MATERIALS, INCLUDING PUTTY, BINETICS, TRAY, MONOPHASE AND CONTACT | Kettenbach GmbH & Co. KG | 2008-09-08 | Traditional | PDF ↗ |
| K082157 | KETTOSIL AND SILGINAT | Kettenbach GmbH & Co. KG | 2008-08-06 | Traditional | PDF ↗ |
| K081017 | TEMPLATE AND COUNTER-FIT | Clinician'S Choice Dental Products, Inc. | 2008-08-04 | Traditional | PDF ↗ |
| K081084 | COLORISE RIGID | Zhermack S.P.A. | 2008-05-14 | Special | PDF ↗ |
| K081120 | FUTAR (FUTAR, FUTAR D, FUTAR D FAST, FUTAR D SLOW, FUTAR SCAN BITE REGISTRATION MATERIALS | Kettenbach GmbH & Co. KG | 2008-05-01 | Traditional | PDF ↗ |
| K080338 | CUTTERSIL ACTIVATOR UNIVERSAL PLUS | Heraeus Kulzer,GmbH | 2008-04-21 | Traditional | PDF ↗ |
Product code ELW · Class II · Dental. Data: openFDA.