Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
ELW — Predicate Candidate Screening
402 FDA 510(k) clearances under this product code; the 50 most recent screened below.
70 daysmedian FDA review time
191 days90th percentile
402clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254112 | Dia-X Sil Bite | DiaDent Group International | 2026-03-19 | 90 | 0 |
| K253501 | Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Pr | Vigodent Indústria E Comercio Ltda | 2025-10-31 | 1 | 0 |
| K250969 | JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST | Dent4you AG | 2025-06-27 | 88 | 0 |
| K241924 | Elastic Impression Material | Beijing Okvd Biological Technology , Ltd. | 2024-12-27 | 179 | 0 |
| K242360 | Speedex Light Body; Speedex Medium; Speedex Putty; Speedex P | Dent4you AG | 2024-11-15 | 98 | 0 |
| K233954 | Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu | B&E Korea Co., Ltd. | 2024-02-13 | 60 | 0 |
| K223892 | DentMix VPS Impression Material | Innovative Product Brands, Inc. | 2023-04-27 | 120 | 0 |
| K213175 | No Stress Impress | No Stress Impress, LLC | 2023-01-19 | 478 | 0 |
| K214086 | Bright Impress-Light, Bright Impress-Medium, Bright Impress- | Genoss Co., Ltd. | 2022-12-15 | 353 | 0 |
| K222741 | DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fas | Hdi, Inc. | 2022-11-07 | 59 | 0 |
| K213244 | Accusil Dental Impression Materials (Accusil Light Body Regu | Prevest Denpro Limited | 2022-09-09 | 344 | 0 |
| K221668 | Dental Impression Material | Chemoment Materials Co.,Ltd | 2022-08-08 | 61 | 0 |
| K213890 | IMICRYL Impression Materials | Imicryl Dis Malzemeleri San. VE Tic. A.S. | 2022-02-11 | 60 | 0 |
| K220257 | Permadyne | 3M Deutschland GmbH | 2022-02-01 | 1 | 0 |
| K220097 | PRESIDENT The Original | Coltène/Whaledent AG | 2022-01-13 | 1 | 0 |
| K211489 | Dental Impression Material | Nanchang Dental Bright Technology Co., Ltd. | 2021-07-28 | 76 | 0 |
| K203824 | VPS Impression Material | Hygedent, Inc. | 2021-04-19 | 111 | 0 |
| K210041 | HySil Plus Impression Materials | Osstem Implant Co., Ltd. | 2021-03-18 | 70 | 0 |
| K201483 | Impression Material | Zhengzhou Huaer Electro Optics Technology Co., Ltd. | 2020-10-08 | 126 | 0 |
| K201684 | A-Silicone for Bite Registration | Shandong Huge Dental Material Corporation | 2020-09-24 | 94 | 0 |
| K201184 | Lascod Impression Materials | Lascod Spa | 2020-05-05 | 4 | 0 |
| K192941 | HySil Super Fast Impression Materials | Osstem Implant Co., Ltd. | 2020-01-30 | 104 | 0 |
| K190571 | StoneBite and StoneBite scan | Dreve Dentamid GmbH | 2019-11-07 | 246 | 0 |
| K191034 | VPS Impression Material | Hygedent, Inc. | 2019-09-04 | 139 | 0 |
| K181604 | Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bi | Hrs Co., Ltd. | 2018-11-28 | 162 | 0 |
| K181236 | HySil Impression Materials | Osstem Implant Co., Ltd. | 2018-09-13 | 126 | 0 |
| K181011 | AIM2 | GC America, Inc. | 2018-07-12 | 86 | 0 |
| K180565 | PEAK NS033CF, PEAK NS017CF | Neosil Co., Ltd. | 2018-06-13 | 100 | 0 |
| K171562 | Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dyn | Dreve Dentamid GmbH | 2018-04-13 | 318 | 0 |
| K173318 | Rapid HB, Rapid LB, Rapid MB | 3M Deutschland GmbH | 2017-10-31 | 11 | 0 |
| K170812 | HygePLUS Alginate Impression Material | Hygedent, Inc. | 2017-07-26 | 131 | 0 |
| K170736 | HySil Impression Materials | Osstem Implant Co., Ltd. | 2017-06-07 | 89 | 0 |
| K152615 | Vonflex S | Vericom Co., Ltd. | 2016-11-03 | 416 | 0 |
| K161774 | i-Sil | Spident Co., Ltd. | 2016-09-30 | 94 | 0 |
| K160097 | Image Fast Set, Image Regular Set | Sybron Dental Specialties | 2016-08-05 | 199 | 0 |
| K160441 | Identic and KromaFaze Alginate Dental Impression Materials | Kerr Corporation | 2016-06-30 | 134 | 0 |
| K152826 | NoCord | Centrix, Inc. | 2016-05-27 | 241 | 0 |
| K152766 | CharmFlex | Dentkist, Inc. | 2016-03-08 | 166 | 0 |
| K152861 | Aquasil Ultra + Smart Wetting Impression Material | Dentply International, Inc. | 2016-03-04 | 156 | 0 |
| K152518 | Vonflex S Putty | Vericom Co., Ltd. | 2015-11-30 | 88 | 0 |
| K152349 | Star+ VPS Scannable Impression Material | Danville Materials, LLC | 2015-11-23 | 95 | 0 |
| K151535 | Cavex Cream Alginate | Cavex Holland BV | 2015-10-28 | 142 | 0 |
| K152180 | PEAK | Neosil Co., Ltd. | 2015-10-22 | 79 | 0 |
| K151262 | Hyflex Heavy, Hyflex Mono, Hyflex Light | Osstem Implant Co., Ltd. | 2015-09-21 | 131 | 0 |
| K151150 | Elements | Pac-Dent International, Inc. | 2015-07-28 | 89 | 0 |
| K143575 | Accu-Dent XD Tray, Accu-Dent XD Syringe | Ivoclar Vivadent, Inc. | 2015-04-03 | 107 | 0 |
| K143382 | DentiAnn Smart Sil | Seilglobal Co., Ltd. | 2015-02-23 | 90 | 0 |
| K141092 | MARK3 | Cavex Holland BV | 2014-12-04 | 220 | 0 |
| K140966 | VONFLEX S BITE | Vericom Co., Ltd. | 2014-08-15 | 122 | 0 |
| K132869 | SILDENT | Hrs Co., Ltd. | 2014-06-19 | 279 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda