Cleared Traditional

K061689 - AQUATINE EC ENDODONTIC CLEANSER (FDA 510(k) Clearance)

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

Submission Details

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.

Device Classification

Product Code KJJ Cleanser, Root Canal
Device Class -

Regulatory Peers - KJJ Cleanser, Root Canal

All 40
Devices cleared under the same product code (KJJ) and FDA review panel - the closest regulatory comparables to K061689.
RC-SwiftPrep
K250279 · Belport Company, Inc., Gingi-Pak · Jul 2025
Sealer Solvent
K241354 · Inter-Med, Inc. · Aug 2024
EPIEN Dental Cleanser
K201785 · Epien Medical, Inc. · Sep 2021
Triton
K211813 · Inter-Med / Vista Dental · Aug 2021
V-Mix
K193357 · Inter-Med/Vista Dental Products · Oct 2020
Vista Rinse, Vista Rinse Plus
K193409 · Inter-Med/Vista Dental Products · Sep 2020