Cleared Traditional

K061689 - AQUATINE EC ENDODONTIC CLEANSER

K061689 · Puricore, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2006
Decision
70d
Days
-
Risk

K061689 is an FDA 510(k) clearance for the AQUATINE EC ENDODONTIC CLEANSER. Classified as Cleanser, Root Canal (product code KJJ).

Submitted by Puricore, Inc. (Radnor, US). The FDA issued a Cleared decision on August 24, 2006 after a review of 70 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Puricore, Inc. devices

FDA 510(k) Submission Details - K061689

510(k) Number K061689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2006
Decision Date August 24, 2006
Days to Decision 70 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
57d faster than avg
Panel avg: 127d · This submission: 70d
Pathway characteristics
Predicate-based equivalence.

KJJ Device Classification - Class 0,

Product Code KJJ Cleanser, Root Canal
Device Class -

Regulatory Peers - KJJ Cleanser, Root Canal

All 18
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