510(k) Report

510(k) · Cleared

Cleared

Modification to Computed Oral Radiology System

K093453510(k) SpecialCleared Nov 30, 200925-day reviewClass II21 CFR 872.1810

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

Schick Technologies, Inc. · EAP Unit, X-Ray, Intraoral

Cleared on Nov 30, 2009 as substantially equivalent to K072134 (Schick Technologies, Inc., 2007) and 3 other predicates after a 25-day review. Its family tree reaches back 3 generations to 1994.

Decided
Nov 30, 2009
Review
25 days
Class
Class II
Product code
EAP
Recalls
None
Predicates
4

Its longest line of descent runs back 3 generations to K933455 (1994). 4 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2004: 1 other ancestorK933455 · Computed Oral Radiology System · Schick Technologies, Inc. · 1994K022953 · Modification to Computed Oral Radiology System · Schick Technologies, Inc. · 2002K072134 · Schick Computed Oral Radiology System · Schick Technologies, Inc. · 200719901995200020052010
Other ancestors, by generation 1 generation back: 1 other ancestor K072134 · Schick Computed Oral Radiology System · Schick Technologies, Inc. · 2007K022953 · Modification to Computed Oral Radiology System · Schick Technologies, Inc. · 2002K933455 · Computed Oral Radiology System · Schick Technologies, Inc. · 19940
  1. Root · 3 generations backK933455 Computed Oral Radiology SystemSchick Technologies, Inc. · 1994
  2. 2 generations backK022953 Modification to Computed Oral Radiology SystemSchick Technologies, Inc. · 2002
  3. 1 generation backK072134 Schick Computed Oral Radiology SystemSchick Technologies, Inc. · 2007
  4. This deviceK093453 Modification to Computed Oral Radiology SystemSchick Technologies, Inc. · 2009
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K933455Computed Oral Radiology SystemSchick Technologies, Inc.1994—
−2K022953Modification to Computed Oral Radiology SystemSchick Technologies, Inc.2002—
−1K072134Schick Computed Oral Radiology SystemSchick Technologies, Inc.2007—
0 (this device)K093453Modification to Computed Oral Radiology SystemSchick Technologies, Inc.2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200410
FIG. 1 — Lineage of K093453, 1994–2009Source: 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 EAP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (4)

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
*K072134Schick Computed Oral Radiology System
Summary page 1
…Howard Fidel, Prepared: November 20, 2009 A. Legally Marketed Predicate Devices The Computed Oral Radiology System was most recently cleared on November 2, 2007 under K072134. Other prior clearances include K041385, K022953 and K933455. The device and its predicates are small digital imaging receptors t…
Schick Technologies, Inc.2007—
*K041385Modification to Computed Oral Radiology System
Summary page 1
…09 A. Legally Marketed Predicate Devices The Computed Oral Radiology System was most recently cleared on November 2, 2007 under K072134. Other prior clearances include K041385, K022953 and K933455. The device and its predicates are small digital imaging receptors that may be used in place of dental x-ray…
Schick Technologies, Inc.2004—
*K022953Modification to Computed Oral Radiology System
Summary page 1
…gally Marketed Predicate Devices The Computed Oral Radiology System was most recently cleared on November 2, 2007 under K072134. Other prior clearances include K041385, K022953 and K933455. The device and its predicates are small digital imaging receptors that may be used in place of dental x-ray film. B…
Schick Technologies, Inc.2002—
*K933455Computed Oral Radiology System
Summary page 1
…ed Predicate Devices The Computed Oral Radiology System was most recently cleared on November 2, 2007 under K072134. Other prior clearances include K041385, K022953 and K933455. The device and its predicates are small digital imaging receptors that may be used in place of dental x-ray film. B. Modificati…
Schick Technologies, Inc.1994—

Also cleared against K072134: 11 other devices →

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 15 years and passes through 1 company; a new generation was cleared every 5.1 years on median.
  • None of the 4 ancestors has a recall.
  • 11 other devices also cite its predicate K072134.

How does its category compare?

All EAP devices

EAP Unit, X-Ray, Intraoral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · EAP

1in 2012

2008: 12009: 12011: 12012: 1
2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EAP

Too few EAP 510(k)s in any year since 2007 to give a median.

Recalls per year · EAP

3in 2012

2012: 3
2007high 3 (2012) · low 0 (2007)2026

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

Adverse event reports per year · EAP

1in 2025

2007: 62008: 182009: 22018: 52019: 32021: 12022: 22023: 122025: 1
2007high 18 (2008) · low 0 (2010)2025

MAUDE reports naming product code EAP, 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
20070—06
20081—018
20091—02
20100—00
20111—00
20121—30
20130—00
20140—00
20150—00
20160—00
20170—00
20180—05
20190—03
20200—00
20210—01
20220—02
20230—012
20240—00
20250—01
20260—0—

What is it indicated for?

The Computed Oral Radiography System is indicated for patients undergoing an intra-oral dental X-ray examination. It produces instant digital intra-oral X-ray images of a patient's mouth.

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

Also cleared against K072134

11 other devices cite the same predicate.

  • K220277Digital Intraoral X-ray SensorShenzhen Xpectvision Technology Co., Ltd. · 2022
  • K150823EDLENi Intra-Oral SensorEdlen Imaging, LLC · 2015
  • K133206Z-Ray Intra-Oral Digital Radiography SystemZuma Dental, LLC · 2014
  • K130088Port View, Digital X-Ray Sensor SystemGenoray Co., Ltd. · 2013
  • K112380ClearvisionMidmark Corp. · 2011
  • K103290Edlen Imaging - Gemini DusbEdlen Imaging, LLC · 2011

More from Schick Technologies, Inc.

13 FDA decisions under this applicant name. See the company

  • K110768Computed Dental RadiographySchick Technologies, Inc. · 2011
  • K072134Schick Computed Oral Radiology SystemSchick Technologies, Inc. · 2007
  • K053558Ceph, Model 4900Schick Technologies, Inc. · 2006
  • K041385Modification to Computed Oral Radiology SystemSchick Technologies, Inc. · 2004
  • K031291CDR Panx, Model 4792Schick Technologies, Inc. · 2003

Recent decisions in EAP

The EAP category page

  • K113360Medical Image Processing UnitHumanray Co,Ltd · 2012
  • K102573Provu (TM) Dental X-Ray SystemAdvanced Image Science, Inc. · 2011
  • K080738Dentron SensorDentron Systems, LLC · 2008
  • K052422The Envision Intraoral Dental X-Ray Machines (Wall Mounted and Mobile)Flow X-Ray Corp. · 2005
  • K041385Modification to Computed Oral Radiology SystemSchick Technologies, Inc. · 2004

https://510kreport.com/device/K093453 · printed Nov 6, 2026

Cite this page

510(k) Report. “K093453: Modification to Computed Oral Radiology System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093453

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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