510(k) Report

510(k) · Cleared

Cleared

Ipt Capsule Mixer

K922203510(k) TraditionalCleared Jun 3, 199223-day reviewClass I21 CFR 872.3100

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

Ipt Technologies, Inc. · EFD Amalgamator, Dental, Ac-Powered

Cleared on Jun 3, 1992 after a 23-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Jun 3, 1992
Review
23 days
Class
Class I
Product code
EFD
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 K922203Source: 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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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 EFD devices

EFD Amalgamator, Dental, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EFD

FDA has decided no EFD device since 2007.

Median 510(k) review, days · EFD

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

Recalls per year · EFD

1so far in 2026, the most since 2007

2026 (partial year): 1
2007high 1 (2026) · low 0 (2007)2026

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

Adverse event reports per year · EFD

1in 2025

2014: 22018: 12021: 12025: 1
2007high 2 (2014) · low 0 (2007)2025

MAUDE reports naming product code EFD, 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—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—02
20150—00
20160—00
20170—00
20180—01
20190—00
20200—00
20210—01
20220—00
20230—00
20240—00
20250—01
20260—1—

Recent decisions in EFD

The EFD category page

  • K991913Pentamix 2Espe Dental AG · 1999
  • K923974Silimat PlusIvoclar North America, Inc. · 1992
  • K915847Automix Dental AmalgamatorKerr Corporation (Danbury) · 1992
  • K914341Mixomat AmalgamatorDegussa AG · 1991
  • K914340Duomat 3 AmalgamatorDegussa AG · 1991

https://510kreport.com/device/K922203 · printed Nov 5, 2026

Cite this page

510(k) Report. “K922203: Ipt Capsule Mixer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K922203

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