510(k) · Cleared
ClearedDigital Dental Intra Oral Sensor, EzSensor Classic, EzSensor HD, HDI-P, HDI-S
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rayence Co., Ltd. · MUH System, X-Ray, Extraoral Source, Digital
Cleared on Nov 10, 2015 as substantially equivalent to K150797 (Rayence Co., Ltd., 2015) after a 20-day review. Its family tree reaches back 5 generations to 1994. 2 later devices descend from it.
- Decided
- Nov 10, 2015
- Review
- 20 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K933455 (1994). 6 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK933455 Computed Oral Radiology SystemSchick Technologies, Inc. · 1994
- 4 generations backK022953 Modification to Computed Oral Radiology SystemSchick Technologies, Inc. · 2002
- 3 generations backK072134 Schick Computed Oral Radiology SystemSchick Technologies, Inc. · 2007
- 2 generations backK090526 Medical Image Processing Unit, Model EzsensorE-Woo Technology · 2009
- 1 generation backK150797 Digital Dental Intra Oral Sensor, EzSensor SmartRayence Co., Ltd. · 2015
- This deviceK153060 Digital Dental Intra Oral Sensor, EzSensor Classic, EzSensor HD…Rayence Co., Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK230916 WeSensorPicopack, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK200625 I-View Gold and Imagen Gold Dental SensorsTrident S.R.L · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K933455 | Computed Oral Radiology System | Schick Technologies, Inc. | 1994 | — |
| −4 | K022953 | Modification to Computed Oral Radiology System | Schick Technologies, Inc. | 2002 | — |
| −3 | K072134 | Schick Computed Oral Radiology System | Schick Technologies, Inc. | 2007 | — |
| −2 | K090526 | Medical Image Processing Unit, Model Ezsensor | E-Woo Technology | 2009 | — |
| −1 | K150797 | Digital Dental Intra Oral Sensor, EzSensor Smart | Rayence Co., Ltd. | 2015 | — |
| 0 (this device) | K153060 | Digital Dental Intra Oral Sensor, EzSensor Classic, EzSensor HD, HDI-P, HDI-S | Rayence Co., Ltd. | 2015 | — |
| +1 | K230916 | WeSensor | Picopack, Inc. | 2023 | — |
| +1 | K200625 | I-View Gold and Imagen Gold Dental Sensors | Trident S.R.L | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MUH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MUH device
- #1 K242778 X Sensor (Model: IOS-A15IF, HDI-15DGF)score 16.0 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K150797 | Digital Dental Intra Oral Sensor, EzSensor SmartSummary page 5…15VB, IOS-U10VB, IOS-U15IB, IOS-U10IB, HDI-U15DB, HDI-U10DB, HDI-U15DF, HDI-U10DF 510(k) Number : K150797 (Decision Date – May 1, 2015) The Regulation Number : 21 CFR 872.1800 Classification Name… | 2015 |
| † | K150747 | EzDent-i /E2/Prora View | 2015 |
| † | K143753 | Digital Dental Intra Oral Sensor, EzSensor Soft, EzSensor Bio | 2015 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 5.1 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K230916 (Picopack, Inc., 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MUH devicesMUH System, X-Ray, Extraoral Source, Digital: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · MUH
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MUH
159in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MUH
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUH
1in 2025
MAUDE reports naming product code MUH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 11 | 48 | 0 | 0 |
| 2008 | 8 | 64 | 1 | 0 |
| 2009 | 9 | 88 | 2 | 12 |
| 2010 | 9 | 174 | 0 | 9 |
| 2011 | 10 | 89 | 0 | 0 |
| 2012 | 9 | 81 | 0 | 5 |
| 2013 | 9 | 172 | 1 | 1 |
| 2014 | 8 | 168 | 1 | 5 |
| 2015 | 12 | 111 | 1 | 3 |
| 2016 | 6 | 47 | 0 | 1 |
| 2017 | 9 | 84 | 0 | 4 |
| 2018 | 3 | 29 | 0 | 10 |
| 2019 | 5 | 64 | 0 | 6 |
| 2020 | 5 | 36 | 0 | 0 |
| 2021 | 10 | 80 | 0 | 1 |
| 2022 | 7 | 57 | 0 | 0 |
| 2023 | 11 | 57 | 0 | 1 |
| 2024 | 4 | 144 | 0 | 0 |
| 2025 | 3 | 159 | 0 | 1 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Digital Dental Intra Oral Sensor is intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed and manipulated for diagnostic use by dentists.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153060 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153060: Digital Dental Intra Oral Sensor, EzSensor Classic, EzSensor HD, HDI-P, HDI-S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153060
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026