FDA product code · Dental
ELWMaterial, Impression
Product code ELW covers Material, Impression, a Class II device regulated under 21 CFR 872.3660. FDA has cleared 402 devices in this code, 2 of them in the last 12 months. Median review time across the 402 most recent decisions is 70 days. openFDA lists 14 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 872.3660
- Review panel
- Dental
- Clearances
- 402
What is happening in ELW right now?
ELW (Material, Impression) has two findings, most consequential first. 2 first-time filers in the last 12 months, DiaDent Group International and VIGODENT INDUSTRIA E COMERCIO LTDA (K254112, K253501). The code is crowded, scoring 76 of 100 — 153 companies hold a clearance here and 2 arrived in the last 12 months (ELW:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| New entrant | Worth knowing | K254112, K253501 |
| Crowding | Context | ELW:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in ELW?
FDA has cleared 402 devices under product code ELW since the 510(k) programme began in 1976, 2 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254112 | Dia-X Sil Bite | DiaDent Group International | |
| 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 | |
| K250969 | JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST | Dent4you AG | |
| K241924 | Elastic Impression Material | Beijing Okvd Biological Technology , Ltd. | |
| K242360 | Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator | Dent4you AG | |
| K233954 | Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu | B&E Korea Co., Ltd. | |
| K223892 | DentMix VPS Impression Material | Innovative Product Brands, Inc. | |
| K213175 | No Stress Impress | No Stress Impress, LLC | |
| K214086 | Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty | Genoss Co., Ltd. | |
| K222741 | DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast) | Hdi, Inc. |
How long does FDA review take for ELW?
The median FDA review time for ELW is 70 days, measured across the 402 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in ELW?
openFDA lists 14 recall records against product code ELW. A recall record covers one firm's corrective action and may span many device lots.
Z-1100-2022TerminatedClinician's Choice Dental Products Inc.
Wrong compression material - Template Ultra Quick matrix Material was packaged instead of the Heavy Body viscosity as indicated on the outer packaging of the 12PK
Z-0717-2017TerminatedIvoclar Vivadent, Inc.
The firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase.
Z-0718-2017TerminatedIvoclar Vivadent, Inc.
The firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase.
Z-0719-2017TerminatedIvoclar Vivadent, Inc.
The firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase.
Z-0535-2014Terminated3M Company - Health Care Business
Specific lots of Imprint II and Paradigm impression material refill packs are being recalled because the moisture displacement feature in both is greatly reduced which may impact the quality of the dental impression.
Showing the 5 most recently initiated of 14. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for ELW?
MAUDE holds 31 adverse-event reports naming product code ELW, 11 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in ELW unusual?
ELW does not yet have twelve months of adverse-event history in our data, so there is no expected range to compare against. That is a gap in what we hold, not a statement about the device.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 12 | Insufficient history | No expected range — too little history | |
| 11 | Insufficient history | No expected range — too little history |
9 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike.
Who has entered ELW in the last year?
2 companies filed in ELW for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| DiaDent Group International | K254112 | |
| VIGODENT INDUSTRIA E COMERCIO LTDA | K253501 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in ELW?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in ELW?
Across the 402 most recent decisions, these applicants filed most often in ELW.
| Applicant | Recent clearances |
|---|---|
| Zhermack S.P.A. | 19 |
| Dentsply Intl. | 18 |
| Cavex Holland BV | 16 |
| GC America, Inc. | 15 |
| Heraeus Kulzer, Inc. | 15 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
One company in ELW files under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Heraeus Kulzer, LLC. | 21 | 3 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch ELW
Get an email the morning anything changes in ELW — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.