FDA product code · Dental
EIAUnit, Operative Dental
Product code EIA covers Unit, Operative Dental, a Class I device regulated under 21 CFR 872.6640. FDA has cleared 284 devices in this code, 1 of them in the last 12 months. Median review time across the 284 most recent decisions is 88 days. openFDA lists 4 recall records against this code.
Updated · ingest status · JSON
- Class
- Class I
- Regulation
- 21 CFR 872.6640
- Review panel
- Dental
- Clearances
- 284
What is happening in EIA right now?
EIA (Unit, Operative Dental): nothing changed in the six FDA sources we watch.
Checked predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Nothing changed, so there is nothing here — which is the point. We only write when something did.
How many devices has FDA cleared in EIA?
FDA has cleared 284 devices under product code EIA since the 510(k) programme began in 1976, 1 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251626 | Midmark Dental Delivery System | Midmark Corporation | |
| K251491 | K5 Cart, K5 Mount, K5 Swing | Osstem Implant Company., Ltd. Chair Business | |
| K243130 | Integral Dental Unit | Guangdong Yadeng Medical Apparatus Co., Ltd., | |
| K242611 | Integral Dental Units | Mipont Medical Equipment Co., Ltd. | |
| K250473 | Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus | Dci International, LLC | |
| K242404 | BDC Dental Unit | Bdc Dental Corporation , Ltd. | |
| K231297 | Firstar Dental Unit | Firstar Dental Company | |
| K233805 | K5 | Osstem Implant Co., Ltd. Chair Business | |
| K240754 | N2 | Megagen Implant Co., Ltd. | |
| K231845 | Dental unit Model: Mare | Foshan Safety Medical Equipment Co., Ltd. |
How long does FDA review take for EIA?
The median FDA review time for EIA is 88 days, measured across the 284 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 EIA?
openFDA lists 4 recall records against product code EIA. A recall record covers one firm's corrective action and may span many device lots.
Z-2530-2016TerminatedDanville Materials, Inc.
The Perioscopy Sheaths are currently provided with a label that indicates the Sheath has a 3 year shelf-life/expiry date. Danville Materials has become aware that validation data are not available to support the 3-year shelf-life/expiration dating claim.
Z-1576-2014TerminatedWilliam C. Domb, D.M.D., A Professional Corporation
William Domb is recalling the Enaly 1000 BT-12 Ozone Generator because it is not approved or cleared by the FDA for medical use.
Z-0545-2014TerminatedASI Medical, Inc.
ASI Medical is initiating a field correction for the SEAC Advanced Dental System because the miniature plastic air tank can potentially rupture.
Z-1177-2012TerminatedPelton & Crane Company
Modification of the Pelton & Crane Spirit 3000 unit disabled the TLC SAFEdrive feature rendering it ineffective in detecting whether the handpiece is potentially damaged or heating up.
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 EIA?
MAUDE holds 148 adverse-event reports naming product code EIA, 22 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 EIA unusual?
EIA 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 |
|---|---|---|---|
| 9 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 14 | 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 | |
| 8 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 8 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 16 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 17 | Insufficient history | No expected range — too little history | |
| 10 | Insufficient history | No expected range — too little history | |
| 11 | Insufficient history | No expected range — too little history | |
| 12 | Insufficient history | No expected range — too little history | |
| 8 | Insufficient history | No expected range — too little history | |
| 13 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 8 | Insufficient history | No expected range — too little history |
19 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.
What are the predicate devices in EIA?
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 EIA?
Across the 284 most recent decisions, these applicants filed most often in EIA.
| Applicant | Recent clearances |
|---|---|
| A-Dec, Inc. | 25 |
| Aseptico, Inc. | 5 |
| Ace Surgical Supply Co., Inc. | 4 |
| Air Techniques, Inc. | 4 |
| Scitech Solutions, Inc. | 4 |
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 EIA 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 |
|---|---|---|
| Pelton & Crane Company | 5 | 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 EIA
Get an email the morning anything changes in EIA — 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.