510(k) Report

510(k) · Cleared

Cleared

Examix Dispenser

K880849510(k) TraditionalCleared May 11, 198871-day reviewClass I21 CFR 872.4565

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

G-C Intl. Corp. · EKJ Burnisher, Operative

Cleared on May 11, 1988 after a 71-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.

Decided
May 11, 1988
Review
71 days
Class
Class I
Product code
EKJ
Recalls
None
Predicates
0

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

Descendants, by year cleared 1996: 1 descendant cleared2012: 1 descendant cleared2013: 1 descendant cleared2014: 3 descendants cleared1990200020102020
  1. This deviceK880849 Examix DispenserG-C Intl. Corp. · 1988
  2. Descendant · cites it directly · 5 of its ownK963766 3M Proplus System3M Company · 1996
  3. Descendant · 2 generations on · 4 of its ownK120438 Flash (Different Materials)3M Deutschland GmbH · 2012
  4. Descendant · 3 generations on · 2 of its ownK131404 Flash AR Penta / Flash AR Penta Quick3M Deutschland GmbH · 2013
  5. Descendant · 3 generations on · 0 of its ownK140602 Flash Penta MB Quick, Flash MB Quick3M Espe AG · 2014
  6. Descendant · 4 generations on · 0 of its ownK133436 Flash AR; Flash AR Quick3M Deutschland GmbH · 2014

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

1996: 12012: 12013: 12014: 3
1996high 3 (2014) · low 0 (1997)2026

Most influential descendants

Showing 5 of 6 · See all
  • K9637663M Proplus System3M Company · 1996 · cites it directly5descendants
  • K120438Flash (Different Materials)3M Deutschland GmbH · 2012 · 2 generations on4descendants
  • K131404Flash AR Penta / Flash AR Penta Quick3M Deutschland GmbH · 2013 · 3 generations on2descendants
  • K140602Flash Penta MB Quick, Flash MB Quick3M Espe AG · 2014 · 3 generations on0descendants
  • K133436Flash AR; Flash AR Quick3M Deutschland GmbH · 2014 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K880849Examix DispenserG-C Intl. Corp.1988—
+1K9637663M Proplus System3M Company1996—
+2K120438Flash (Different Materials)3M Deutschland GmbH2012—
+3K131404Flash AR Penta / Flash AR Penta Quick3M Deutschland GmbH2013—
+3K140602Flash Penta MB Quick, Flash MB Quick3M Espe AG2014—
+4K133436Flash AR; Flash AR Quick3M Deutschland GmbH2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
201210
201310
201430
FIG. 1 — Lineage of K880849, 1988–2014Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in EKJ? 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?

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

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K9637663M Proplus System3M Company19965

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, K963766 (3M Company, 1996) has gone furthest, with 5 descendants of its own.

How does its category compare?

All EKJ devices

EKJ Burnisher, Operative: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EKJ

FDA has decided no EKJ device since 2007.

Median 510(k) review, days · EKJ

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

Recalls per year · EKJ

No recall names EKJ since 2007.

Adverse event reports per year · EKJ

2in 2015

2011: 12015: 2
2007high 2 (2015) · low 0 (2007)2025

MAUDE reports naming product code EKJ, 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—00
20080—00
20090—00
20100—00
20110—01
20120—00
20130—00
20140—00
20150—02
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from G-C Intl. Corp.

23 FDA decisions under this applicant name. See the company

  • K913175Miracle Mix Caps Glass Ionomer Cement IncapsulesG-C Intl. Corp. · 1991
  • K913884Fuji II LCG-C Intl. Corp. · 1991
  • K901999Fuji Lining Cement Light CureG-C Intl. Corp. · 1990
  • K902531Exaphase, Single Phase Impression MaterialG-C Intl. Corp. · 1990
  • K896883GC Cervical CementG-C Intl. Corp. · 1990

Recent decisions in EKJ

The EKJ category page

  • K961714Aseptylum, Uni-CarrierDistriflor S.A. · 1996
  • K953707Medtrol Dental KitMedtrol, Inc. · 1996
  • K945815Dental KitConstancy Ent., Inc. · 1995
  • K951607Sureflex FilesDentsply Intl. · 1995
  • K945077Instrument,Filling,Plastic,DentalWorldwide Dental, Inc. · 1994

https://510kreport.com/device/K880849 · printed Nov 6, 2026

Cite this page

510(k) Report. “K880849: Examix Dispenser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K880849

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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