Cleared Traditional

K030895 - ASEPTICO ENDOPEX V

K030895 · Aseptico, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2003
Decision
257d
Days
-
Risk

K030895 is an FDA 510(k) clearance for the ASEPTICO ENDOPEX V, MODEL AEU-40. Classified as Locator, Root Apex (product code LQY).

Submitted by Aseptico, Inc. (Woodinville, US). The FDA issued a Cleared decision on December 3, 2003 after a review of 257 days - an extended review cycle.

This device falls under the Dental FDA review panel. 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 Aseptico, Inc. devices

Submission Details

510(k) Number K030895 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2003
Decision Date December 03, 2003
Days to Decision 257 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
130d slower than avg
Panel avg: 127d · This submission: 257d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LQY Locator, Root Apex
Device Class -

Regulatory Peers - LQY Locator, Root Apex

All 19
Devices cleared under the same product code (LQY) and FDA review panel - the closest regulatory comparables to K030895.
Apex Locator, DPEX III
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Dr’s Finder NEO
K171867 · Good Doctors Co., Ltd. · Mar 2018
MULTIPLE (APEX LOCATOR), MODEL RCM-7
K090925 · J. Morita USA, Inc. · Nov 2009
DENTA PORT
K022147 · J. Morita USA, Inc. · Dec 2002
FORAMATRON V, MODEL D680
K002195 · Parkell, Inc. · Aug 2000
APEX FINDER MODELS 7005
K962803 · Sybron Dental Specialties, Inc. · Oct 1996