510(k) Report

510(k) · Cleared

Cleared

Ceramic Orthodonit Appliance

K852179510(k) TraditionalCleared Aug 20, 198592-day reviewClass I21 CFR 872.5410

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

Gac Intl., Inc. · EJF Bracket, Metal, Orthodontic

Cleared on Aug 20, 1985 after a 92-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 39 later devices descend from it.

Decided
Aug 20, 1985
Review
92 days
Class
Class I
Product code
EJF
Recalls
None
Predicates
0

39 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2009: 5 descendants cleared2008: 2 descendants cleared2005: 2 descendants cleared2006: 1 descendant cleared2016: 3 descendants cleared2012: 4 descendants cleared2011: 2 descendants cleared2022: 2 descendants cleared2018: 4 descendants cleared2014: 2 descendants cleared2017: 1 descendant cleared2013: 1 descendant cleared2023: 4 descendants cleared2020: 2 descendants cleared2019: 3 descendants cleared1990200020102020
  1. This deviceK852179 Ceramic Orthodonit ApplianceGac Intl., Inc. · 1985
  2. Descendant · cites it directly · 38 of its ownK042178 Orthodontic Ceramic BracketsDentsply Intl. · 2004
  3. Descendant · 2 generations on · 23 of its ownK082974 Mystique MB Ceramic BracketsDentsply Interntional · 2008
  4. Descendant · 2 generations on · 20 of its ownK060837 IN-Ovation CDentsply International · 2006
  5. Descendant · 3 generations on · 15 of its ownK102803 Clarity Advanced Ceramic Brackets3M Unitek Corporation · 2011
  6. Descendant · 3 generations on · 7 of its ownK123094 Orthodontic Ceramic BracketsTomy, Inc. · 2012

Showing 5 of 39 descendants. See all descendants

Descendants cleared per year

2004: 12005: 22006: 12008: 22009: 52011: 22012: 42013: 12014: 22016: 32017: 12018: 42019: 32020: 22022: 22023: 4
2004high 5 (2009) · low 0 (2007)2026

Most influential descendants

Showing 5 of 39 · See all
  • K042178Orthodontic Ceramic BracketsDentsply Intl. · 2004 · cites it directly38descendants
  • K082974Mystique MB Ceramic BracketsDentsply Interntional · 2008 · 2 generations on23descendants
  • K060837IN-Ovation CDentsply International · 2006 · 2 generations on20descendants
  • K102803Clarity Advanced Ceramic Brackets3M Unitek Corporation · 2011 · 3 generations on15descendants
  • K123094Orthodontic Ceramic BracketsTomy, Inc. · 2012 · 3 generations on7descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K852179Ceramic Orthodonit ApplianceGac Intl., Inc.1985—
+1K042178Orthodontic Ceramic BracketsDentsply Intl.2004—
+2K082974Mystique MB Ceramic BracketsDentsply Interntional2008—
+2K060837IN-Ovation CDentsply International2006—
+3K102803Clarity Advanced Ceramic Brackets3M Unitek Corporation2011—
+3K123094Orthodontic Ceramic BracketsTomy, Inc.2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200520
200610
200820
200950
201120
201240
201310
201420
201630
201710
201840
201930
202020
202220
202340
FIG. 1 — Lineage of K852179, 1985–2023Source: 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 EJF? 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? (39)

See all 39

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K042178Orthodontic Ceramic BracketsDentsply Intl.200438
K090454Allure MB Ceramic BracketsDentsply Interntional20095

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, K042178 (Dentsply Intl., 2004) has gone furthest, with 38 descendants of its own.

How does its category compare?

All EJF devices

EJF Bracket, Metal, Orthodontic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EJF

FDA has decided no EJF device since 2007.

Median 510(k) review, days · EJF

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

Recalls per year · EJF

1in 2013

2009: 12012: 12013: 1
2007high 1 (2009) · low 0 (2007)2026

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

Adverse event reports per year · EJF

3in 2025

2007: 22008: 72009: 192010: 182011: 122012: 52013: 72014: 82015: 92016: 52017: 82018: 32019: 12020: 42021: 12022: 72023: 62024: 22025: 3
2007high 19 (2009) · low 1 (2019)2025

MAUDE reports naming product code EJF, 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—02
20080—07
20090—119
20100—018
20110—012
20120—15
20130—17
20140—08
20150—09
20160—05
20170—08
20180—03
20190—01
20200—04
20210—01
20220—07
20230—06
20240—02
20250—03
20260—0—

More from Gac Intl., Inc.

13 FDA decisions under this applicant name. See the company

  • K981036SmartbondGac Intl., Inc. · 1999
  • K942826Orthodonitc Metal Reinforced Plastic BracketGac Intl., Inc. · 1994
  • K933542Mesial Loop BarGac Intl., Inc. · 1994
  • K932825Microarch Gold BracketGac Intl., Inc. · 1994
  • K932319Orthodontic ElastomerGac Intl., Inc. · 1993

Recent decisions in EJF

The EJF category page

  • K994357Bitem Lock, Models SW006, SW012Thermoelastic Technologies, Inc. · 2000
  • K932825Microarch Gold BracketGac Intl., Inc. · 1994
  • K933501AlastikUnitek Corp. · 1994
  • K923372Memory WireAlthan, Inc. · 1994
  • K933080Orthotech Dura-Gold BarcketsOrthotech · 1994

https://510kreport.com/device/K852179 · printed Nov 6, 2026

Cite this page

510(k) Report. “K852179: Ceramic Orthodonit Appliance.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K852179

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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