510(k) Report

510(k) · Cleared

Cleared

WDS, Size 2 and Size 2

K061114510(k) AbbreviatedCleared Jun 6, 200646-day reviewClass II21 CFR 872.1800

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cefla S.C.R.L. · MUH System, X-Ray, Extraoral Source, Digital

Cleared on Jun 6, 2006 as substantially equivalent to K031448 (Visiodent SA, 2003) and 2 other predicates after a 46-day review. Its family tree reaches back 1 generation to 1999. 5 later devices descend from it.

Decided
Jun 6, 2006
Review
46 days
Class
Class II
Product code
MUH
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K990002 (1999). 3 ancestors in all. 5 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 1 other ancestor2003: 1 other ancestor2010: 1 descendant cleared2008: 1 descendant cleared2009: 1 descendant cleared2011: 1 descendant cleared2024: 1 descendant clearedK990002 · Quickray DSX 730 · Julie Alliance · 19991995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 2 descendants2 generations forward: 1 descendant3 generations forward: 1 descendant4 generations forward: 1 descendant K990002 · Quickray DSX 730 · Julie Alliance · 19990
  1. Root · 1 generation backK990002 Quickray DSX 730Julie Alliance · 1999
  2. This deviceK061114 WDS, Size 2 and Size 2Cefla S.C.R.L. · 2006
  3. Descendant · cites it directly · 3 of its ownK080738 Dentron SensorDentron Systems, LLC · 2008
  4. Descendant · 2 generations on · 2 of its ownK092537 Digital X-Ray Sensor, Model E9539,E9505,E9502, E9540Toshiba America Electronic Components, Inc. · 2009
  5. Descendant · 3 generations on · 1 of its ownK110886 Clio/CliosoftSota Precision Optics, Inc. · 2011
  6. Descendant · 4 generations on · 0 of its ownK241495 Jazz ClassicJazz Imaging · 2024
  7. Descendant · cites it directly · 0 of its ownK100960 WDS X-Pod and Zen-X Digital X-Ray SensorsCefla Dental Group · 2010

Most influential descendants

Showing 5 of 5 · See all
  • K080738Dentron SensorDentron Systems, LLC · 2008 · cites it directly3descendants
  • K092537Digital X-Ray Sensor, Model E9539,E9505,E9502, E9540Toshiba America Electronic Components, Inc. · 2009 · 2 generations on2descendants
  • K110886Clio/CliosoftSota Precision Optics, Inc. · 2011 · 3 generations on1descendant
  • K241495Jazz ClassicJazz Imaging · 2024 · 4 generations on0descendants
  • K100960WDS X-Pod and Zen-X Digital X-Ray SensorsCefla Dental Group · 2010 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K990002Quickray DSX 730Julie Alliance1999—
0 (this device)K061114WDS, Size 2 and Size 2Cefla S.C.R.L.2006—
+1K080738Dentron SensorDentron Systems, LLC2008—
+2K092537Digital X-Ray Sensor, Model E9539,E9505,E9502, E9540Toshiba America Electronic Components, Inc.2009—
+3K110886Clio/CliosoftSota Precision Optics, Inc.2011—
+4K241495Jazz ClassicJazz Imaging2024—
+1K100960WDS X-Pod and Zen-X Digital X-Ray SensorsCefla Dental Group2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200310
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
200910
201010
201110
202410
FIG. 1 — Lineage of K061114, 1999–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K242778 X Sensor (Model: IOS-A15IF, HDI-15DGF)score 16.0 · 7 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K031448RSV (Radiology System Visiodent
Summary page 1
…additional components such as conventional X-ray tube and image capture software, currently available commercially * Summary of Substantial Equivalence Comparison: K03 1448, RSV, VISIODENT K050693 ACCENT, AIR TECHNIQUES, INC K990002 QUICKRAY DSX73O, JULIE ALLIANCE The proposed and predicated devic…
Visiodent SA2003—
*K050693Accent
Summary page 1
…h as conventional X-ray tube and image capture software, currently available commercially * Summary of Substantial Equivalence Comparison: K03 1448, RSV, VISIODENT K050693 ACCENT, AIR TECHNIQUES, INC K990002 QUICKRAY DSX73O, JULIE ALLIANCE The proposed and predicated devices use similar components…
Air Techniques, Inc.2005—
*K990002Quickray DSX 730
Summary page 1
…e capture software, currently available commercially * Summary of Substantial Equivalence Comparison: K03 1448, RSV, VISIODENT K050693 ACCENT, AIR TECHNIQUES, INC K990002 QUICKRAY DSX73O, JULIE ALLIANCE The proposed and predicated devices use similar components and are similar in design, technical…
Julie Alliance1999—

Also cleared against K031448: 2 other devices →

What descends from it? (5)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K080738Dentron SensorDentron Systems, LLC20083
K100960WDS X-Pod and Zen-X Digital X-Ray SensorsCefla Dental Group20100

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?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K080738 (Dentron Systems, LLC, 2008) has gone furthest, with 3 descendants of its own.
  • 2 other devices also cite its predicate K031448.

How does its category compare?

All MUH devices

MUH System, X-Ray, Extraoral Source, Digital: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MUH

3in 2025

2007: 112008: 82009: 92010: 92011: 102012: 92013: 92014: 82015: 122016: 62017: 92018: 32019: 52020: 52021: 102022: 72023: 112024: 42025: 32026 (partial year): 2
2007high 12 (2015) · low 3 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MUH

159in 2025

2007: 48 days median2008: 64 days median2009: 88 days median2010: 174 days median2011: 89 days median2012: 81 days median2013: 172 days median2014: 168 days median2015: 111 days median2016: 47 days median2017: 84 days median2018: 29 days median2019: 64 days median2020: 36 days median2021: 80 days median2022: 57 days median2023: 57 days median2024: 144 days median2025: 159 days median
2007high 174 (2010) · low 29 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MUH

1in 2015

2008: 12009: 22013: 12014: 12015: 1
2007high 2 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MUH

1in 2025

2009: 122010: 92012: 52013: 12014: 52015: 32016: 12017: 42018: 102019: 62021: 12023: 12025: 1
2007high 12 (2009) · low 0 (2007)2025

MAUDE reports naming product code MUH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007114800
200886410
2009988212
2010917409
2011108900
201298105
2013917211
2014816815
20151211113
201664701
201798404
2018329010
201956406
202053600
2021108001
202275700
2023115701
2024414400
2025315901
20262—0—

What is it indicated for?

the wireless digital RX sensor is intended to capture an intraoral digital RX image, when exposed to X-Rays, for diagnostic purposes.

The process is automatic and continues transmitting to a Personal Computer the digital image by wireless Bluetooth connection.

Indications for use as stated in the FDA summary.

Also cleared against K031448

2 other devices cite the same predicate.

  • K053172Universal-X (Usa) or /Krystal-X (Europe)Owandy Sas · 2006
  • K060640Digirex Digital Dental Radiography SystemDentamerica · 2006

More from Cefla S.C.R.L.

3 FDA decisions under this applicant name. See the company

  • K080076RX DC X-Ray UnitCefla S.C.R.L. · 2008
  • K062897C-U2Cefla S.C.R.L. · 2006

Recent decisions in MUH

The MUH category page

  • K261663EzSensor HDQpix Solutions, Inc. · 2026
  • K251793SOTA Cloud Smart Sensor (1.5)Sota Cloud Corp. · 2026
  • K252570EzSensor HD, EzSensor UHDQpix Solutions, Inc. · 2025
  • K250687Cocoon Solo (DX-7020s)Dexcowin Global, Inc. · 2025
  • K251206Digital X-Ray DentiMax Pro Imaging SystemDentimax, Inc. · 2025

https://510kreport.com/device/K061114 · printed Nov 6, 2026

Cite this page

510(k) Report. “K061114: WDS, Size 2 and Size 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061114

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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