Cleared Traditional

K030895 - ASEPTICO ENDOPEX V, MODEL AEU-40

K030895 · Aseptico, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K030895

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
129d slower than avg
Panel avg: 128d · This submission: 257d
Pathway characteristics
Predicate-based equivalence.

LQY Device Classification - Class 0,

Product Code LQY Locator, Root Apex
Device Class -

Regulatory Peers - LQY Locator, Root Apex

All 45
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K030895 · ASEPTICO ENDOPEX V, MODEL AEU-40
Download PDF FDA Summary Aseptico, Inc.