Cleared Traditional

K102234 - A-DEC 200 DENTAL SYSTEM (FDA 510(k) Clearance)

Class I Dental device.

K102234 · A-Dec, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2010
Decision
107d
Days
Class 1
Risk

K102234 is an FDA 510(k) clearance for the A-DEC 200 DENTAL SYSTEM. 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 November 24, 2010 after a review of 107 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 K102234 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2010
Decision Date November 24, 2010
Days to Decision 107 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 127d · This submission: 107d
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.

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