510(k) Report

510(k) · Cleared

Cleared

Steadfast Denture Adhesive Powder

K910216510(k) TraditionalCleared Mar 29, 199171-day reviewClass I21 CFR 872.3400

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

Stiefel Research Institute, Inc. · KOM Adhesive, Denture, Acacia And Karaya With Sodium Borate

Cleared on Mar 29, 1991 after a 71-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Mar 29, 1991
Review
71 days
Class
Class I
Product code
KOM
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K910216Source: 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.

Planning a device in KOM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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  • 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?

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 KOM devices

KOM Adhesive, Denture, Acacia And Karaya With Sodium Borate: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KOM

FDA has decided no KOM device since 2007.

Median 510(k) review, days · KOM

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

Recalls per year · KOM

No recall names KOM since 2007.

Adverse event reports per year · KOM

1in 2009

2007: 22009: 1
2007high 2 (2007) · low 0 (2008)2025

MAUDE reports naming product code KOM, 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—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Stiefel Research Institute, Inc.

6 FDA decisions under this applicant name. See the company

  • K914591L.C.S. 2000 SystemStiefel Research Institute, Inc. · 1992
  • K895818Steadfast Denture Adhesive CreamStiefel Research Institute, Inc. · 1990
  • K895817Hermal Wound Care KitStiefel Research Institute, Inc. · 1990
  • K896724Cryojet Liquid Nitrogen Spray Cryosurgical Instru.Stiefel Research Institute, Inc. · 1990
  • K893996Cusis Ultrasound Skin Imaging SystemStiefel Research Institute, Inc. · 1989

https://510kreport.com/device/K910216 · printed Nov 6, 2026

Cite this page

510(k) Report. “K910216: Steadfast Denture Adhesive Powder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K910216

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