Cleared Traditional

K923354 - PORT OPII, PORT OPIII

K923354 is an FDA 510(k) clearance for PORT OPII, manufactured by Mobile Dental Equipment Corp.. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 454-day FDA review.

K923354 · Mobile Dental Equipment Corp. · Dental device
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Oct 1993
Decision
454d
Days
Class 1
Risk

K923354 is an FDA 510(k) clearance for the PORT OPII, PORT OPIII. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Mobile Dental Equipment Corp. (Bellevue, US). The FDA issued a Cleared decision on October 5, 1993 after a review of 454 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Mobile Dental Equipment Corp. devices

FDA 510(k) Submission Details - K923354

510(k) Number K923354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1992
Decision Date October 05, 1993
Days to Decision 454 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
327d slower than avg
Panel avg: 127d · This submission: 454d
Pathway characteristics
Predicate-based equivalence.

EIA Device Classification - Class 1, General Controls

Product Code EIA Unit, Operative Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
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 - EIA Unit, Operative Dental

All 189
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K923354.
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K933168 · A-Dec, Inc. · Oct 1993
MDT/CASTLE PURUS DENTAL UNIT
K914697 · Mdt Corp., Inc. · Nov 1991
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K905011 · Concord/Portex · Jan 1991