Cleared Traditional

K925798 - A-DEC 2545 DUO IC MICRO-CART

K925798 is the FDA 510(k) clearance for A-DEC 2545 DUO IC MICRO-CART by A-Dec, Inc.. It is a Class 1 Dental device (product code EIA) cleared through the Traditional 510(k) pathway after a 416-day FDA review.

K925798 · A-Dec, Inc. · Dental device
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Jan 1994
Decision
416d
Days
Class 1
Risk

K925798 is an FDA 510(k) clearance for the A-DEC 2545 DUO IC MICRO-CART. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by A-Dec, Inc. (Newberg, US). The FDA issued a Cleared decision on January 6, 1994 after a review of 416 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 A-Dec, Inc. devices

Submission Details

510(k) Number K925798 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1992
Decision Date January 06, 1994
Days to Decision 416 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
289d slower than avg
Panel avg: 127d · This submission: 416d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 60
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K925798.
A-DEC RADIUS 2122/2132
K940893 · A-Dec, Inc. · Jul 1994
A-DEC CASCADE 3072 WALLMOUNT
K935325 · A-Dec, Inc. · Apr 1994
A-DEC 2544 DOCTORS IC MICRO-CART
K925797 · A-Dec, Inc. · Jan 1994
A-DEC 2611 ASSISTANT'S CART
K933166 · A-Dec, Inc. · Oct 1993
A-DEC 2912 DUO CART
K933167 · A-Dec, Inc. · Oct 1993
A-DEC 2612 ASSISTANT'S CART
K933163 · A-Dec, Inc. · Oct 1993