510(k) Report

510(k) · Cleared

Cleared

Mediadent HDX/MMD HDX SP Xray Sensor

K002425510(k) TraditionalCleared Dec 21, 2000135-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

Multi Media Dental Systems, Inc. · MUH System, X-Ray, Extraoral Source, Digital

Cleared on Dec 21, 2000 after a 135-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Dec 21, 2000
Review
135 days
Class
Class II
Product code
MUH
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared200020052010201520202025
  1. This deviceK002425 Mediadent HDX/MMD HDX SP Xray SensorMulti Media Dental Systems, Inc. · 2000
  2. Descendant · cites it directly · 0 of its ownK023292 Apex Hri Digital Radiography SystemKrugman Technologies, Inc. · 2002

Most influential descendants

Showing 1 of 1 · See all
  • K023292Apex Hri Digital Radiography SystemKrugman Technologies, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K002425Mediadent HDX/MMD HDX SP Xray SensorMulti Media Dental Systems, Inc.2000—
+1K023292Apex Hri Digital Radiography SystemKrugman Technologies, Inc.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
FIG. 1 — Lineage of K002425, 2000–2002Source: 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), 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K023292Apex Hri Digital Radiography SystemKrugman Technologies, Inc.20020

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?

  • Of its descendants, K023292 (Krugman Technologies, Inc., 2002) has gone furthest, with 0 descendants of its own.

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—

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The MUH category page

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https://510kreport.com/device/K002425 · printed Nov 3, 2026

Cite this page

510(k) Report. “K002425: Mediadent HDX/MMD HDX SP Xray Sensor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K002425

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026