FDA product code · Dental
EBIResin, Denture, Relining, Repairing, Rebasing
Product code EBI covers Resin, Denture, Relining, Repairing, Rebasing, a Class II device regulated under 21 CFR 872.3760. FDA has cleared 332 devices in this code, 9 of them in the last 12 months. Median review time across the 332 most recent decisions is 85 days. openFDA lists 16 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 872.3760
- Review panel
- Dental
- Clearances
- 332
What is happening in EBI right now?
EBI (Resin, Denture, Relining, Repairing, Rebasing) has two findings, most consequential first. 6 first-time filers in the last 12 months, including Formlabs Ohio, Inc. and Carbon, Inc (K262300, K260569, K253365, K253324, K252430). The code is crowded, scoring 94 of 100 — 164 companies hold a clearance here and 9 arrived in the last 12 months (EBI:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| New entrant | Worth knowing | K262300, K260569, K253365, K253324, K252430 |
| Crowding | Context | EBI: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 EBI?
FDA has cleared 332 devices under product code EBI since the 510(k) programme began in 1976, 9 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262300 | Denture Base Resin V2 | Formlabs Ohio, Inc. | |
| K261474 | DENTCA Tru Flexible | Dentca, Inc. | |
| K260569 | DB 4000 High Impact Denture Base | Carbon, Inc. | |
| K260376 | Denture Base | Shandong Huge Dental Material Corporation | |
| K253365 | LuxCreo Flexible Partial Denture Resin | LuxCreo, Inc. | |
| K253681 | 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) | Graphy, Inc. | |
| K253324 | UltraPrint-Dental Denture UV | Guangzhou Heygears IMC., Inc. | |
| K252430 | Freeprint® denture flex | Detax GmbH | |
| K252035 | 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) | Kamemizu Chemical Industry Co., Ltd. | |
| K250302 | Flexible Partial Resin | Prismatik Dentalcraft, Inc. |
How long does FDA review take for EBI?
The median FDA review time for EBI is 85 days, measured across the 332 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 EBI?
openFDA lists 16 recall records against product code EBI. A recall record covers one firm's corrective action and may span many device lots.
Z-2090-2025CompletedSTRATASYS LTD
Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired material.
Z-2091-2025CompletedSTRATASYS LTD
Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired material.
Z-2092-2025CompletedSTRATASYS LTD
Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired material.
Z-2093-2025CompletedSTRATASYS LTD
Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired material.
Z-2094-2025CompletedSTRATASYS LTD
Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired material.
Showing the 5 most recently initiated of 16. 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 EBI?
MAUDE holds 45 adverse-event reports naming product code EBI, 1 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 EBI unusual?
EBI 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 |
|---|---|---|---|
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 26 | Insufficient history | No expected range — too little history | |
| 3 | 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 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 EBI in the last year?
6 companies filed in EBI for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Formlabs Ohio, Inc. | K262300 | |
| Carbon, Inc. | K260569 | |
| LuxCreo, Inc. | K253365 | |
| Guangzhou Heygears IMC., Inc. | K253324 | |
| Detax GmbH | K252430 | |
| Kamemizu Chemical Industry Co., Ltd. | K252035 |
"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 EBI?
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 EBI?
Across the 332 most recent decisions, these applicants filed most often in EBI.
| Applicant | Recent clearances |
|---|---|
| Dentsply Intl. | 16 |
| GC America, Inc. | 12 |
| Heraeus Kulzer, Inc. | 11 |
| Harry J. Bosworth Co. | 8 |
| Voco GmbH | 8 |
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 EBI 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. | 13 | 2 |
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 EBI
Get an email the morning anything changes in EBI — 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.