Cleared Traditional

K101332 - AMC-20 PORTABLE DENTAL CART MODEL AMC-20

K101332 is an FDA 510(k) clearance for AMC-20 PORTABLE DENTAL CART MODEL AMC-20, manufactured by Aseptico, Inc.. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 334-day FDA review.

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

FDA 510(k) Submission Details - K101332

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
207d slower than avg
Panel avg: 127d · This submission: 334d
Pathway characteristics
Predicate-based equivalence.

EIA Device Classification - Class 1, General Controls

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 154
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K101332.
TRITON SELF CONTAINED DENTAL SYSTEM, TRITON SELF CONTAINED DENTAL SYSTEM, WITH CASE
K110481 · Asi Medical, Inc. · Apr 2012
DYNAMIC DU SERIES PORTABLE DENTAL UNIT
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CS 1200
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YOBOSHI DENTAL UNIT
K103550 · Fosham Yoboshi Medical Equipment Co., Ltd. · Jan 2011
A-DEC 200 DENTAL SYSTEM
K102234 · A-Dec, Inc. · Nov 2010
STERN'S S250 NORDAM
K092917 · Cefla S.C. · Jun 2010