FDA product code · Dental
EMACement, Dental
Product code EMA covers Cement, Dental, a Class II device regulated under 21 CFR 872.3275. FDA has cleared 506 devices in this code, 10 of them in the last 12 months. Median review time across the 506 most recent decisions is 75 days. openFDA lists 16 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 872.3275
- Review panel
- Dental
- Clearances
- 506
What is happening in EMA right now?
EMA (Cement, Dental) has three findings, most consequential first. 2 first-time filers in the last 12 months, Inter-Med Llc and Belport Company, Inc., Gingi-Pak (K253337, K251775). Clearances are running 35% slower — a median 101 days over the last 12 months against 75 days all-time (elapsed calendar days, not FDA review days) (EMA:review_time:12m). The code is crowded, scoring 86 of 100 — 163 companies hold a clearance here and 10 arrived in the last 12 months (EMA:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| New entrant | Worth knowing | K253337, K251775 |
| Review time | Context | EMA:review_time:12m |
| Crowding | Context | EMA: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 EMA?
FDA has cleared 506 devices under product code EMA since the 510(k) programme began in 1976, 10 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261166 | DIA-CEM | DiaDent Group International | |
| K254109 | G-CEM UNIVERSAL | GC America, Inc. | |
| K253337 | REGEN Bioactive Cement | Inter-Med, Inc. | |
| K252606 | Bifix Veneer LC, Bifix Veneer Try-In | Voco GmbH | |
| K254063 | iCEM Universal Plus | Kulzer, LLC | |
| K252785 | TopCEM Vigor SA Self-Adhesive Resin Cement | Rizhao Huge Biomaterials Company, Ltd. | |
| K252808 | GlasIonomer FX-LC | Shofu Dental Corporation | |
| K252165 | ZIRCONOMER P | Shofu Dental Corporation | |
| K250953 | EQUIA LC ONE | GC America, Inc. | |
| K251775 | RODIN Cement | Belport Company, Inc., Gingi-Pak |
How long does FDA review take for EMA?
The median FDA review time for EMA is 75 days, measured across the 506 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 EMA?
openFDA lists 16 recall records against product code EMA. A recall record covers one firm's corrective action and may span many device lots.
Z-1142-2024Open, ClassifiedVoco GmbH
Due to an error in the manufacturing process, it is possible that an incorrect plunger has been fitted to some capsules. This plunger does not contain the correct reactive component for Ionolux. When these capsules are activated, curing is significantly delayed and incomplete. Processing according to the instructions for use is not possible.
Z-1143-2024Open, ClassifiedVoco GmbH
Due to an error in the manufacturing process, it is possible that an incorrect plunger has been fitted to some capsules. This plunger does not contain the correct reactive component for Ionolux. When these capsules are activated, curing is significantly delayed and incomplete. Processing according to the instructions for use is not possible.
Z-0265-2024Open, ClassifiedFamily Dollar Stores, Llc.
Products were stored outside of labeled temperature requirements.
Z-1226-2023Open, ClassifiedPreat Corp
Product is labeled with an incorrect expiration date.
Z-1529-2022Open, ClassifiedFamily Dollar Stores, Llc.
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
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 EMA?
MAUDE holds 19 adverse-event reports naming product code EMA, 3 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 EMA unusual?
EMA 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 | |
| 2 | 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 | |
| 2 | 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 | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history |
13 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 EMA in the last year?
2 companies filed in EMA for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Inter-Med Llc | K253337 | |
| Belport Company, Inc., Gingi-Pak | K251775 |
"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 EMA?
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 EMA?
Across the 506 most recent decisions, these applicants filed most often in EMA.
| Applicant | Recent clearances |
|---|---|
| GC America, Inc. | 30 |
| Voco GmbH | 26 |
| Dentsply Intl. | 19 |
| Shofu Dental Corp. | 16 |
| 3M Company | 12 |
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 EMA 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 |
|---|---|---|
| Shofu Dental Corporation | 24 | 2 |
| Pulpdent Corporation | 14 | 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 EMA
Get an email the morning anything changes in EMA — 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.