Cleared Abbreviated

APTUS BLUE (K030884) - FDA 510(k) Clearance

K030884 · Acadental · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2003
Decision
68d
Days
-
Risk

K030884 is an FDA 510(k) clearance for the APTUS BLUE. Classified as Cleanser, Root Canal (product code KJJ).

Submitted by Acadental (Mission, US). The FDA issued a Cleared decision on May 27, 2003 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

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Submission Details

510(k) Number K030884 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2003
Decision Date May 27, 2003
Days to Decision 68 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 127d · This submission: 68d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code KJJ Cleanser, Root Canal
Device Class -