FDA product code · Dental
EIHPowder, Porcelain
Product code EIH covers Powder, Porcelain, a Class II device regulated under 21 CFR 872.6660. FDA has cleared 485 devices in this code, 13 of them in the last 12 months. Median review time across the 485 most recent decisions is 87 days. openFDA lists 35 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 872.6660
- Review panel
- Dental
- Clearances
- 485
What is happening in EIH right now?
EIH (Powder, Porcelain) has three findings, most consequential first. 1 recall opened in the last 12 months and not yet terminated (Class II) (Z-2356-2026). 4 first-time filers in the last 12 months, including Zima International Inc., dba Dandy and Dental Creativ Management GmbH (K262195, K253191, K260067, K251593). The code is crowded, scoring 96 of 100 — 214 companies hold a clearance here and 13 arrived in the last 12 months (EIH:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-2356-2026 |
| New entrant | Worth knowing | K262195, K253191, K260067, K251593 |
| Crowding | Context | EIH: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 EIH?
FDA has cleared 485 devices under product code EIH since the 510(k) programme began in 1976, 13 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261046 | Dental Zirconia Blank & Coloring Liquid | Hunan Qinghao Puzhong Technology Co., Ltd. | |
| K262195 | Dandy Ceramic Stain and Glaze | Zima International Inc., dba Dandy | |
| K260918 | Zolid Lunaris | Amann Girrbach AG | |
| K260859 | Rosetta SM, Rosetta SP | Hass Corp. | |
| K253191 | DCMhotbond zircon | Dental Creativ Management GmbH | |
| K260067 | Eternal Art Porcelain Powders | Shandong Huge Dental Material Corporation | |
| K260370 | Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Bloomden Bioceramics (HuNan) Co., Ltd. | |
| K253953 | IPS e.max Zirconia | Ivoclar Vivadent, Inc. | |
| K254283 | BruxZir® Shaded 16 PLUS | Prismatik Dentalcraft, Inc. | |
| K253973 | Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series | Liaoning Upcera Co., Ltd. |
How long does FDA review take for EIH?
The median FDA review time for EIH is 87 days, measured across the 485 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 EIH?
openFDA lists 35 recall records against product code EIH. A recall record covers one firm's corrective action and may span many device lots.
Z-2356-2026Open, ClassifiedSagemax Bioceramics, Inc.
Yttrium-stabilized zirconium oxide discs for fixed all-ceramic dental restorations may have reduced or missing dentin layer and when used clinically in the patient's mouth there is an increased risk of fractures under functional stress.
Z-1703-2024Open, ClassifiedIvoclar Vivadent, Inc.
Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
Z-1704-2024Open, ClassifiedIvoclar Vivadent, Inc.
Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
Z-1705-2024Open, ClassifiedIvoclar Vivadent, Inc.
Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
Z-1706-2024Open, ClassifiedIvoclar Vivadent, Inc.
Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
Showing the 5 most recently initiated of 35. 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 EIH?
MAUDE holds 10 adverse-event reports naming product code EIH, 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 EIH unusual?
EIH 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 | |
| 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 | |
| 2 | 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 EIH in the last year?
4 companies filed in EIH for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Zima International Inc., dba Dandy | K262195 | |
| Dental Creativ Management GmbH | K253191 | |
| Shandong Huge Dental Material Corporation | K260067 | |
| Denmat Holding, LLC | K251593 |
"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 EIH?
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 EIH?
Across the 485 most recent decisions, these applicants filed most often in EIH.
| Applicant | Recent clearances |
|---|---|
| Dentsply Intl. | 23 |
| Prismatik Dentalcraft, Inc. | 20 |
| Vident | 16 |
| Noritake Co., Inc. | 14 |
| Wieland Dental + Technik GmbH & Co. KG | 14 |
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 EIH 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 |
|---|---|---|
| Shofu Dental Corporation | 15 | 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 EIH
Get an email the morning anything changes in EIH — 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.