FDA product code · Dental
MUHSystem, X-Ray, Extraoral Source, Digital
Product code MUH covers System, X-Ray, Extraoral Source, Digital, a Class II device regulated under 21 CFR 872.1800. FDA has cleared 206 devices in this code, 4 of them in the last 12 months. Median review time across the 206 most recent decisions is 72 days. openFDA lists 9 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 872.1800
- Review panel
- Dental
- Clearances
- 206
What is happening in MUH right now?
MUH (System, X-Ray, Extraoral Source, Digital) has two findings, most consequential first. 2 first-time filers in the last 12 months, SOTA CLOUD CORPORATION and Dexcowin Global, Inc (K251793, K250687). The code is crowded, scoring 76 of 100 — 111 companies hold a clearance here and 4 arrived in the last 12 months (MUH:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| New entrant | Worth knowing | K251793, K250687 |
| Crowding | Context | MUH: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 MUH?
FDA has cleared 206 devices under product code MUH since the 510(k) programme began in 1976, 4 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251793 | SOTA Cloud Smart Sensor (1.5) | Sota Cloud Corp. | |
| K252570 | EzSensor HD, EzSensor UHD | Qpix Solutions, Inc. | |
| K250687 | Cocoon Solo (DX-7020s) | Dexcowin Global, Inc. | |
| K251206 | Digital X-Ray DentiMax Pro Imaging System | Dentimax, Inc. | |
| K240040 | VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan) | VATECH Co., Ltd. | |
| K242778 | X Sensor (Model: IOS-A15IF, HDI-15DGF) | Qpix Solutions, Inc. | |
| K241649 | DUO1 and DUO2 | Zinnovi, Inc. | |
| K232325 | RAYSCAN a-Expert | Ray Co., Ltd. | |
| K231660 | Digital image scanner of dental | Jiangsu Dynamic Medical Technology Co., Ltd. | |
| K233053 | DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 Intraoral Sensor | Dental Imaging Technologies Corporation |
How long does FDA review take for MUH?
The median FDA review time for MUH is 72 days, measured across the 206 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 MUH?
openFDA lists 9 recall records against product code MUH. A recall record covers one firm's corrective action and may span many device lots.
Z-1387-2019TerminatedKaVo Dental Technologies LLC
The sensor's look up calibration files were incorrectly programmed during manufacturing, which can result in the reduction of image quality.
Z-0128-2016TerminatedVilla Radiology Systems LLC
It has been discovered that due to lack of information accompanying documents the product fails to comply with 21CfR 1020.33(c),1020.33(d),1020.33(g),and 1020.330).
Z-1377-2015TerminatedCarestream Health, Inc.
Units device head descended unexpectedly
Z-1378-2015TerminatedCarestream Health, Inc.
Units device head descended unexpectedly
Z-0651-2016TerminatedMidmark Corp dba Progeny Inc
Failure of the primary collimator may result in unintentional movement of the device. The unintentional movement will not result in the generation of an error message.
Showing the 5 most recently initiated of 9. 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 MUH?
MAUDE holds 2 adverse-event reports naming product code MUH.
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 MUH unusual?
MUH 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 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 MUH in the last year?
2 companies filed in MUH for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| SOTA CLOUD CORPORATION | K251793 | |
| Dexcowin Global, Inc. | K250687 |
"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 MUH?
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 MUH?
Across the 206 most recent decisions, these applicants filed most often in MUH.
| Applicant | Recent clearances |
|---|---|
| VATECH Co., Ltd. | 8 |
| Genoray Co., Ltd. | 7 |
| Sirona Dental Systems GmbH | 7 |
| Trophy | 6 |
| Instrumentarium Dental, Palodex Group OY | 5 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
Source: openFDA device/510k · retrieved
Watch MUH
Get an email the morning anything changes in MUH — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
Related product codes in Dental
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.