Cleared Traditional

K933163 - A-DEC 2612 ASSISTANT'S CART

K933163 is the FDA 510(k) clearance for A-DEC 2612 ASSISTANT'S CART by A-Dec, Inc.. It is a Class 1 Dental device (product code EIA) cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K933163 · A-Dec, Inc. · Dental device
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Oct 1993
Decision
105d
Days
Class 1
Risk

K933163 is an FDA 510(k) clearance for the A-DEC 2612 ASSISTANT'S 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 October 12, 1993 after a review of 105 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all A-Dec, Inc. devices

Submission Details

510(k) Number K933163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 1993
Decision Date October 12, 1993
Days to Decision 105 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
22d faster than avg
Panel avg: 127d · This submission: 105d
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 K933163.
A-DEC 2545 DUO IC MICRO-CART
K925798 · 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 3131 DUO WALLMOUNT (WITH INSTRUMENTATION)
K933165 · A-Dec, Inc. · Oct 1993
A-DEC 3127 ASSISTANT'S WALLMOUNT
K933168 · A-Dec, Inc. · Oct 1993
A-DEC PAC I PORTABLE UNIT
K903451 · A-Dec, Inc. · Oct 1990