510(k) Report

FDA product code · Dental

Wax, Dental, Intraoral

EGDClass I21 CFR 872.6890510(k) exempt25 decisions since 19800 recalls

FDA lists EGD as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 872.9 applies, such as a new intended use or a different fundamental technology. 25 FDA decisions since 1980. No recall names this code. The most-cited predicate is K924024, named by 1 later device.

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

FIG. A — Illustration, dental panel

Twenty years of EGD at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · EGD

FDA has decided no EGD device since 2007.

Median 510(k) review, days · EGD

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

Recalls per year · EGD

No recall names EGD since 2007.

Adverse event reports per year · EGD

1in 2024

2007: 22009: 12010: 22017: 12019: 12024: 1
2007high 2 (2007) · low 0 (2008)2025

MAUDE reports naming product code EGD, 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—00
20090—01
20100—02
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—01
20180—00
20190—01
20200—00
20210—00
20220—00
20230—00
20240—01
20250—00
20260—0—
FIG. 1 — EGD by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in EGD? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do EGD devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K924024Ortho WaxHeraeus Kulzer, Inc. · 19921cites it
  • K020009Brace EzeUdent, Inc. · 20021cites it

Which EGD devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K020009Brace EzeUdent, Inc. · 20021generation

What has FDA decided in EGD lately?

  • K020009Brace EzeUdent, Inc. · 2002
  • K945535Glenroe Ortho-SilGlenroe Technologies · 1995
  • K924024Ortho WaxHeraeus Kulzer, Inc. · 1992
  • K923586Burnout MaterialDentsply Intl. · 1992
  • K914892Saliva-StimOrion Diagnostica, Inc. · 1992
  • K922380Bite Rim WaxDentsply Intl. · 1992

All 25 EGD decisions →

Related product codes

Other codes under 21 CFR 872.6890.

PFL Intraoral, Dental Foam Protector