510(k) Report

510(k) · Cleared

Cleared

CD-Dent Digital Imaging Devices for Dental X-Ray Systems, Models 600, 1000 and 2000

K990049510(k) TraditionalCleared Mar 12, 199964-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

Digident, Ltd. · MUH System, X-Ray, Extraoral Source, Digital

Cleared on Mar 12, 1999 as substantially equivalent to K974619 (Afp Imaging Corp., 1998) and 2 other predicates after a 64-day review. Its family tree reaches back 3 generations to 1989.

Decided
Mar 12, 1999
Review
64 days
Class
Class II
Product code
MUH
Recalls
None
Predicates
3

Its longest line of descent runs back 3 generations to K884621 (1989). 7 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1994: 1 other ancestor1992: 3 other ancestorsK884621 · Digiscan · Siemens Medical Solutions USA, Inc. · 1989K955643 · Alara Imaging System · Denoptix, Inc. · 1996K974619 · Scanaray/CD-Dent Advanced Computerized X-Ray System · Afp Imaging Corp. · 19981985199019952000
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 3 other ancestors K974619 · Scanaray/CD-Dent Advanced Computerized X-Ray System · Afp Imaging Corp. · 1998K955643 · Alara Imaging System · Denoptix, Inc. · 1996K884621 · Digiscan · Siemens Medical Solutions USA, Inc. · 19890
  1. Root · 3 generations backK884621 DigiscanSiemens Medical Solutions USA, Inc. · 1989
  2. 2 generations backK955643 Alara Imaging SystemDenoptix, Inc. · 1996
  3. 1 generation backK974619 Scanaray/CD-Dent Advanced Computerized X-Ray SystemAfp Imaging Corp. · 1998
  4. This deviceK990049 CD-Dent Digital Imaging Devices for Dental X-Ray Systems, Models…Digident, Ltd. · 1999
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K884621DigiscanSiemens Medical Solutions USA, Inc.1989—
−2K955643Alara Imaging SystemDenoptix, Inc.1996—
−1K974619Scanaray/CD-Dent Advanced Computerized X-Ray SystemAfp Imaging Corp.1998—
0 (this device)K990049CD-Dent Digital Imaging Devices for Dental X-Ray Systems, Models 600, 1000 and…Digident, Ltd.1999—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199230
199410
FIG. 1 — Lineage of K990049, 1989–1999Source: 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
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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
*K974619Scanaray/CD-Dent Advanced Computerized X-Ray System
Summary page 1
…aging system S. PREDICATE DEVICES The legally marketed devices to which equivalence is being claimed are: . ScanARay Computerized X-Ray System marketed by AFP Imaging (K974619) Digident Ltd. 510(k) 1/06/99 CD-Dent Digital-Imaging Device for Dental X-Ray Systems Page D-1 . Digora marketed…
Afp Imaging Corp.1998—
*K934949Digora
Summary page 2
…P Imaging (K974619) Digident Ltd. 510(k) 1/06/99 CD-Dent Digital-Imaging Device for Dental X-Ray Systems Page D-1 . Digora marketed by Sorodex-finndent (K934949) . DenOptix System marketed by Gendex (K955643) 6. DEVICE DESCRIPTION The CD-Dent Digital Imaging Devices for Dental X-Ray Syst…
Orion Corporation Soredex1994—
*K955643Alara Imaging System
Summary page 2
…99 CD-Dent Digital-Imaging Device for Dental X-Ray Systems Page D-1 . Digora marketed by Sorodex-finndent (K934949) . DenOptix System marketed by Gendex (K955643) 6. DEVICE DESCRIPTION The CD-Dent Digital Imaging Devices for Dental X-Ray Systems are filmless systems intended for digital i…
Denoptix, Inc.1996—

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 10 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
  • None of the 7 ancestors has a 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?

The CD-Dent Digital-Imaging Devices for Dental X-Ray Systems are intended for digital dental radiography using a phosphor storage screen for radiographic diagnostic intraoral and extraoral images

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Recent decisions in MUH

The MUH category page

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  • K251206Digital X-Ray DentiMax Pro Imaging SystemDentimax, Inc. · 2025

https://510kreport.com/device/K990049 · printed Nov 6, 2026

Cite this page

510(k) Report. “K990049: CD-Dent Digital Imaging Devices for Dental X-Ray Systems, Models 600, 1000 and 2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990049

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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