510(k) Report

510(k) · Cleared

Cleared

Dento-Surge

K955176510(k) TraditionalCleared Apr 15, 1996154-day reviewClass II21 CFR 872.4920

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

Ellman Intl., Inc. · EKZ Unit, Electrosurgical, And Accessories, Dental

Cleared on Apr 15, 1996 after a 154-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.

Decided
Apr 15, 1996
Review
154 days
Class
Class II
Product code
EKZ
Recalls
None
Predicates
0

3 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2005: 2 descendants cleared2017: 1 descendant cleared1995200020052010201520202025
  1. This deviceK955176 Dento-SurgeEllman Intl., Inc. · 1996
  2. Descendant · cites it directly · 2 of its ownK050735 MC6AMacan Engineering Co. · 2005
  3. Descendant · 2 generations on · 0 of its ownK170054 iSurgJaco, LLC Dba Macan Manufacturing and Bna Burz North America · 2017
  4. Descendant · 2 generations on · 0 of its ownK052622 Macan Model MC-4A Dental Electrosurgical UnitMacan Engineering Co. · 2005 · Recalled

Most influential descendants

Showing 3 of 3 · See all
  • K050735MC6AMacan Engineering Co. · 2005 · cites it directly2descendants
  • K170054iSurgJaco, LLC Dba Macan Manufacturing and Bna Burz North America · 2017 · 2 generations on0descendants
  • K052622Macan Model MC-4A Dental Electrosurgical UnitMacan Engineering Co. · 2005 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K955176Dento-SurgeEllman Intl., Inc.1996—
+1K050735MC6AMacan Engineering Co.2005—
+2K170054iSurgJaco, LLC Dba Macan Manufacturing and Bna Burz North America2017—
+2K052622Macan Model MC-4A Dental Electrosurgical UnitMacan Engineering Co.20051

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200520
201710
FIG. 1 — Lineage of K955176, 1996–2017Source: 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 EKZ? 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 EKZ device

  1. #1 K213477 Root ZX3score 5.3 · 6 generations · no Class I recall
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K050735MC6AMacan Engineering Co.20052

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, K050735 (Macan Engineering Co., 2005) has gone furthest, with 2 descendants of its own.

How does its category compare?

All EKZ devices

EKZ Unit, Electrosurgical, And Accessories, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EKZ

1in 2022

2007: 22022: 1
2007high 2 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EKZ

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

Recalls per year · EKZ

No recall names EKZ since 2007.

Adverse event reports per year · EKZ

6in 2018

2009: 12014: 12018: 6
2007high 6 (2018) · low 0 (2007)2025

MAUDE reports naming product code EKZ, 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
20072—00
20080—00
20090—01
20100—00
20110—00
20120—00
20130—00
20140—01
20150—00
20160—00
20170—00
20180—06
20190—00
20200—00
20210—00
20221—00
20230—00
20240—00
20250—00
20260—0—

More from Ellman Intl., Inc.

15 FDA decisions under this applicant name. See the company

  • K013255Surgitron 120 Iec (Also Known as Surgitron 4.0 Dual RFEllman Intl., Inc. · 2001
  • K003126Bipolar Trigger-Flex ProbeEllman Intl., Inc. · 2001
  • K001986Surgitron Iec IIEllman Intl., Inc. · 2000
  • K001407Surgitron Iec IIEllman Intl., Inc. · 2000
  • K001253Surgitron Iec IIEllman Intl., Inc. · 2000

Recent decisions in EKZ

The EKZ category page

  • K213477Root ZX3J. Morita USA, Inc. · 2022
  • K071632Perfect Tissue Contouring System IIColtene/Whaledent, Inc. · 2007
  • K063468The Fugo Blade for DentistryMedisurg, Ltd. · 2007
  • K052622Macan Model MC-4A Dental Electrosurgical UnitMacan Engineering Co. · 20051 recall
  • K050735MC6AMacan Engineering Co. · 2005

https://510kreport.com/device/K955176 · printed Nov 6, 2026

Cite this page

510(k) Report. “K955176: Dento-Surge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K955176

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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