510(k) Report

510(k) · Cleared

Recalled · Class III · 2013

Reflections - Ceramic Dental Bracket

K922499510(k) TraditionalCleared Jul 30, 199264-day reviewClass I21 CFR 872.5410Recalls 1

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

Cdb Corp. · EJF Bracket, Metal, Orthodontic

Cleared on Jul 30, 1992 after a 64-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. It has been recalled once.

Decided
Jul 30, 1992
Review
64 days
Class
Class I
Product code
EJF
Recalls
1
Predicates
0

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

Descendants, by year cleared 2009: 1 descendant cleared2013: 2 descendants cleared1990200020102020
  1. This deviceK922499 Reflections - Ceramic Dental BracketCdb Corp. · 1992
  2. Descendant · cites it directly · 1 of its ownK130446 Fastbraces Ceramic BracketsOrthodontic Design and Production, Inc. · 2013
  3. Descendant · 2 generations on · 0 of its ownK132368 Vapor Ceramic BracketOrthodontic Design and Production, Inc. · 2013
  4. Descendant · cites it directly · 0 of its ownK091702 CDB Flip-Side-Clip BracketCdb Corporation · 2009

Most influential descendants

Showing 3 of 3 · See all
  • K130446Fastbraces Ceramic BracketsOrthodontic Design and Production, Inc. · 2013 · cites it directly1descendant
  • K132368Vapor Ceramic BracketOrthodontic Design and Production, Inc. · 2013 · 2 generations on0descendants
  • K091702CDB Flip-Side-Clip BracketCdb Corporation · 2009 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K922499Reflections - Ceramic Dental BracketCdb Corp.1992—
+1K130446Fastbraces Ceramic BracketsOrthodontic Design and Production, Inc.2013—
+2K132368Vapor Ceramic BracketOrthodontic Design and Production, Inc.2013—
+1K091702CDB Flip-Side-Clip BracketCdb Corporation2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201320
FIG. 1 — Lineage of K922499, 1992–2013Source: 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 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K130446Fastbraces Ceramic BracketsOrthodontic Design and Production, Inc.20131
K091702CDB Flip-Side-Clip BracketCdb Corporation20090

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Feb 8, 2013Class IIIZ-0876-2013PackagingOrthodontic brackets distributed was incorrectly labeled.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K130446 (Orthodontic Design and Production, Inc., 2013) has gone furthest, with 1 descendant 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 Cdb Corp.

3 FDA decisions under this applicant name. See the company

  • K973776ReflectionsCdb Corp. · 1997
  • K934881ReflectionsCdb Corp. · 1994

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/K922499 · printed Nov 5, 2026

Cite this page

510(k) Report. “K922499: Reflections - Ceramic Dental Bracket.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K922499

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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