Cleared Traditional

K922203 - IPT CAPSULE MIXER

K922203 is an FDA 510(k) clearance for IPT CAPSULE MIXER, manufactured by Ipt Technologies, Inc.. The device is a Class 1 Dental device with product code EFD cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K922203 · Ipt Technologies, Inc. · Dental device
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Jun 1992
Decision
23d
Days
Class 1
Risk

K922203 is an FDA 510(k) clearance for the IPT CAPSULE MIXER. Classified as Amalgamator, Dental, Ac-powered (product code EFD), Class I - General Controls.

Submitted by Ipt Technologies, Inc. (Fort Lauderdale, US). The FDA issued a Cleared decision on June 3, 1992 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3100 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ipt Technologies, Inc. devices

FDA 510(k) Submission Details - K922203

510(k) Number K922203 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1992
Decision Date June 03, 1992
Days to Decision 23 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 127d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

EFD Device Classification - Class 1, General Controls

Product Code EFD Amalgamator, Dental, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3100
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EFD Amalgamator, Dental, Ac-powered

All 10
Devices cleared under the same product code (EFD) and FDA review panel - the closest regulatory comparables to K922203.
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