Cleared Traditional

K931204 - AS3000 OPERATIVE DENTAL UNIT (DELIVERY SYSTEM) (FDA 510(k) Clearance)

Class I Dental device.

K931204 · Den-Tal-Ez Mfg Co., Inc. · Dental device
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Jul 1993
Decision
121d
Days
Class 1
Risk

K931204 is an FDA 510(k) clearance for the AS3000 OPERATIVE DENTAL UNIT (DELIVERY SYSTEM). Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Den-Tal-Ez Mfg Co., Inc. (Lancaster, US). The FDA issued a Cleared decision on July 8, 1993 after a review of 121 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 Den-Tal-Ez Mfg Co., Inc. devices

Submission Details

510(k) Number K931204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1993
Decision Date July 08, 1993
Days to Decision 121 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
6d faster than avg
Panel avg: 127d · This submission: 121d
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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