510(k) Report

510(k) · Cleared

Cleared

Glenroe Ortho-Sil

K945535510(k) TraditionalCleared Jan 27, 199574-day reviewClass I21 CFR 872.6890

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

Glenroe Technologies · EGD Wax, Dental, Intraoral

Cleared on Jan 27, 1995 after a 74-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Jan 27, 1995
Review
74 days
Class
Class I
Product code
EGD
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K945535Source: FDA 510(k) database · 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.

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  • 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?

No later submission names this one as a predicate yet.

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.

How does its category compare?

All EGD devices

EGD Wax, Dental, Intraoral: FDA decisions, review times, recalls and adverse event reports over 20 years.

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—

More from Glenroe Technologies

8 FDA decisions under this applicant name. See the company

  • K980053Glenroe ChainGlenroe Technologies · 1998
  • K924351Glenroe Elastibite StimulatorGlenroe Technologies · 1994
  • K932920Glenroe Plastic BracketGlenroe Technologies · 1993
  • K924140Tuff TiesGlenroe Technologies · 1993
  • K924139Glenroe Ortho SepsGlenroe Technologies · 1993

Recent decisions in EGD

The EGD category page

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

https://510kreport.com/device/K945535 · printed Nov 4, 2026

Cite this page

510(k) Report. “K945535: Glenroe Ortho-Sil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K945535

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026