510(k) · Cleared
ClearedZ-Ray Intra-Oral Digital Radiography System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zuma Dental, LLC · MUH System, X-Ray, Extraoral Source, Digital
Cleared on May 13, 2014 as substantially equivalent to K072134 (Schick Technologies, Inc., 2007) and 1 other predicate after a 208-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- May 13, 2014
- Review
- 208 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K933455 (1994). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK933455 Computed Oral Radiology SystemSchick Technologies, Inc. · 1994
- 3 generations backK022953 Modification to Computed Oral Radiology SystemSchick Technologies, Inc. · 2002
- 2 generations backK072134 Schick Computed Oral Radiology SystemSchick Technologies, Inc. · 2007
- 1 generation backK090458 Dexis SensorDexis, LLC · 2009
- This deviceK133206 Z-Ray Intra-Oral Digital Radiography SystemZuma Dental, LLC · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K933455 | Computed Oral Radiology System | Schick Technologies, Inc. | 1994 | — |
| −3 | K022953 | Modification to Computed Oral Radiology System | Schick Technologies, Inc. | 2002 | — |
| −2 | K072134 | Schick Computed Oral Radiology System | Schick Technologies, Inc. | 2007 | — |
| −1 | K090458 | Dexis Sensor | Dexis, LLC | 2009 | — |
| 0 (this device) | K133206 | Z-Ray Intra-Oral Digital Radiography System | Zuma Dental, LLC | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 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? (2)
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 |
|---|---|---|---|
| * | K072134 | Schick Computed Oral Radiology SystemSummary page 1…,per 21 CFR 872.1800 Product Code: MUH Devices for Which Substantial Equivalence is claimed: " Schick Computed Oral Radiography System (K072134) * Dexis Sensor (K090458) Device Description: The Zuma Dental Z-ray x-ray image sensor is a ful… | 2007 |
| * | K090458 | Dexis SensorSummary page 1…uct Code: MUH Devices for Which Substantial Equivalence is claimed: " Schick Computed Oral Radiography System (K072134) * Dexis Sensor (K090458) Device Description: The Zuma Dental Z-ray x-ray image sensor is a fully integrated CMOIS photo… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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 20 years and passes through 3 companies; a new generation was cleared every 5.1 years on median.
- None of the 7 ancestors has a recall.
- 11 other devices also cite its predicate K072134.
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. 2014, 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?
The Z-Ray digital radiography system was designed for the sole purpose of capturing radiographic images of teeth and the surrounding structures limited to the oral cavity. This device should be used under the direction of a licensed Dentist when it is deemed necessary to perform a radiographic series of a patient for diagnostic purposes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133206 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133206: Z-Ray Intra-Oral Digital Radiography System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133206
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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