FDA product code · Dental
EBZActivator, Ultraviolet, For Polymerization
Product code EBZ covers Activator, Ultraviolet, For Polymerization, a Class II device regulated under 21 CFR 872.6070. FDA has cleared 214 devices in this code, 2 of them in the last 12 months. Median review time across the 214 most recent decisions is 65 days. openFDA lists 4 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 872.6070
- Review panel
- Dental
- Clearances
- 214
What is happening in EBZ right now?
EBZ (Activator, Ultraviolet, For Polymerization) has two findings, most consequential first. 2 first-time filers in the last 12 months, Guangzhou Rebornendo Medical Instrument Co., Ltd. and Meta Systems Co., Ltd (K253131, K253461). The code is crowded, scoring 73 of 100 — 120 companies hold a clearance here and 2 arrived in the last 12 months (EBZ:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| New entrant | Worth knowing | K253131, K253461 |
| Crowding | Context | EBZ: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 EBZ?
FDA has cleared 214 devices under product code EBZ 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 |
|---|---|---|---|
| K253131 | Curing Light (M-Cure 6) | Guangzhou Rebornendo Medical Instrument Co., Ltd. | |
| K253461 | Demi Pro | Meta Systems Co., Ltd. | |
| K242386 | Bluemoon | Genoss Co., Ltd. | |
| K243921 | LED Curing Lights (DB686 HALO) | Foshan Coxo Medical Instrument Co., Ltd. | |
| K250009 | LED Curing Light (C01-X, C02-X) | Premium Plus (Dongguan) Limited | |
| K241238 | LOOP LED Curing Light System (CLK01) | Garrison Dental Solutions, LLC | |
| K223414 | Curing Light, Model: MaxCure 9 | Guilin Refine Medical Instrument Co., Ltd. | |
| K233518 | BASE290 LED Curing Light | Handpiece Headquarters | |
| K223507 | CL-DP40 (Drs Light PRIME), CL-DP40 (Drs Light CHOICE) | Good Doctors Co., Ltd. | |
| K223142 | Coltolux Comfort LED Curing Light | Dent4you AG |
How long does FDA review take for EBZ?
The median FDA review time for EBZ is 65 days, measured across the 214 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 EBZ?
openFDA lists 4 recall records against product code EBZ. A recall record covers one firm's corrective action and may span many device lots.
Z-0746-2022Open, ClassifiedEnvisiontec US Llc
The PCA 4000 may not fully cure EnvisionTEC dental resins to desired product specifications.
Z-0797-2019Open, ClassifiedHandpiece Headquarters
Tip of the curing light was too hot causing a heat sensation in the patients.
Z-1740-2014TerminatedIvoclar Vivadent, Inc.
A stock check revealed broken glass fibers between the connector and the fiber bundle in a large number of these light probes.
Z-1505-2012TerminatedO'Ryan Industries Inc
Disposa-Shield Disposable Curing Shield is recalled due to lacking 510K, PMA or IDE, and inadequate quality system.
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 EBZ?
MAUDE holds 12 adverse-event reports naming product code EBZ, 2 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 EBZ unusual?
EBZ 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 | |
| 5 | 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 | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history |
6 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 EBZ in the last year?
2 companies filed in EBZ for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Guangzhou Rebornendo Medical Instrument Co., Ltd. | K253131 | |
| Meta Systems Co., Ltd. | K253461 |
"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 EBZ?
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 EBZ?
Across the 214 most recent decisions, these applicants filed most often in EBZ.
| Applicant | Recent clearances |
|---|---|
| Monitex Industrial Co., Ltd. | 9 |
| Rolence Enterprise Co. , Ltd. | 8 |
| Ultradent Products, Inc. | 7 |
| Ivoclar Vivadent, Inc. | 6 |
| Dentsply Intl. | 5 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
2 companies in EBZ file 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 |
|---|---|---|
| Ivoclar Vivadent, Inc. | 8 | 2 |
| Kerr Corporation | 6 | 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 EBZ
Get an email the morning anything changes in EBZ — 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.