Cleared Traditional

K101332 - AMC-20 PORTABLE DENTAL CART MODEL AMC-20 (FDA 510(k) Clearance)

Class I Dental device.

K101332 · Aseptico, Inc. · Dental device
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Apr 2011
Decision
334d
Days
Class 1
Risk

K101332 is an FDA 510(k) clearance for the AMC-20 PORTABLE DENTAL CART MODEL AMC-20. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Aseptico, Inc. (Woodinville, US). The FDA issued a Cleared decision on April 11, 2011 after a review of 334 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Aseptico, Inc. devices

Submission Details

510(k) Number K101332 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2010
Decision Date April 11, 2011
Days to Decision 334 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
207d slower than avg
Panel avg: 127d · This submission: 334d
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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