510(k) Report

510(k) · Cleared

Cleared

Cleartooth Digital X-Ray System

K033147510(k) TraditionalCleared Dec 30, 200391-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

Cleartooth Electronics, Inc. · MUH System, X-Ray, Extraoral Source, Digital

Cleared on Dec 30, 2003 as substantially equivalent to K013271 (Douglas C. Yoon, Dds, 2001) after a 91-day review. Its family tree reaches back 1 generation to 2001.

Decided
Dec 30, 2003
Review
91 days
Class
Class II
Product code
MUH
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K013271 (2001). No later device cites it as a predicate yet.

K013271 · DXS Digital X-Ray System · Douglas C. Yoon, Dds · 2001200020022004
K013271 · DXS Digital X-Ray System · Douglas C. Yoon, Dds · 20010
  1. Root · 1 generation backK013271 DXS Digital X-Ray SystemDouglas C. Yoon, Dds · 2001
  2. This deviceK033147 Cleartooth Digital X-Ray SystemCleartooth Electronics, Inc. · 2003
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K013271DXS Digital X-Ray SystemDouglas C. Yoon, Dds2001—
0 (this device)K033147Cleartooth Digital X-Ray SystemCleartooth Electronics, Inc.2003—
FIG. 1 — Lineage of K033147, 2001–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K013271DXS Digital X-Ray SystemDouglas C. Yoon, Dds2001—

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?

  • Its one ancestor has no recall.

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?

An extra-oral source x-ray system which is a host PC powered device that produces digital radiographs and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw and supporting oral structures.

Indications for use as stated in the FDA summary.

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/K033147 · printed Nov 3, 2026

Cite this page

510(k) Report. “K033147: Cleartooth Digital X-Ray System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033147

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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