510(k) Report

510(k) · Cleared

Cleared

Profast (R)-Denture Adhesive Cream

K930336510(k) TraditionalCleared Aug 24, 1993214-day reviewClass I21 CFR 868.5570

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

Fittydent-Altwirth & Schmitt GmbH · KGB Mask, Oxygen, Non-Rebreathing

Cleared on Aug 24, 1993 after a 214-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Aug 24, 1993
Review
214 days
Class
Class I
Product code
KGB
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 K930336Source: 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 KGB? 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?

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 KGB devices

KGB Mask, Oxygen, Non-Rebreathing: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KGB

FDA has decided no KGB device since 2007.

Median 510(k) review, days · KGB

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

Recalls per year · KGB

6in 2020

2020: 6
2007high 6 (2020) · low 0 (2007)2026

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

Adverse event reports per year · KGB

4in 2025

2008: 12009: 12010: 12011: 12012: 22013: 22014: 322015: 532016: 222017: 32018: 52019: 12020: 92022: 62023: 22024: 12025: 4
2007high 53 (2015) · low 0 (2007)2025

MAUDE reports naming product code KGB, 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—00
20080—01
20090—01
20100—01
20110—01
20120—02
20130—02
20140—032
20150—053
20160—022
20170—03
20180—05
20190—01
20200—69
20210—00
20220—06
20230—02
20240—01
20250—04
20260—0—

More from Fittydent-Altwirth & Schmitt GmbH

3 FDA decisions under this applicant name. See the company

  • K930335Profast - Denture Adhesive for Lower JawsFittydent-Altwirth & Schmitt GmbH · 1994
  • K930337Profast (R)-Denture CleanserFittydent-Altwirth & Schmitt GmbH · 1993

Recent decisions in KGB

The KGB category page

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  • K960401Ultimate SealHans Rudolph, Inc. · 1996
  • K941336Combo MaskGam Industries, Inc. · 1994
  • K935917Challenge Powder-Free, Hypoallergenic, Synthetic Surgical GlovesBd Becton Dickinson Vacutainer Systems Preanalytic · 1994
  • K932347Compact MaskVital Signs, Inc. · 1994

https://510kreport.com/device/K930336 · printed Nov 4, 2026

Cite this page

510(k) Report. “K930336: Profast (R)-Denture Adhesive Cream.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K930336

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