Cleared Traditional

K032627 - ULTRADENT CITRIC ACID 10% SOLUTION

K032627 · Ultradent Products, Inc. · Dental device
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Nov 2003
Decision
78d
Days
-
Risk

K032627 is an FDA 510(k) clearance for the ULTRADENT CITRIC ACID 10% SOLUTION. Classified as Cleanser, Root Canal (product code KJJ).

Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on November 12, 2003 after a review of 78 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 Ultradent Products, Inc. devices

Submission Details

510(k) Number K032627 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2003
Decision Date November 12, 2003
Days to Decision 78 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 127d · This submission: 78d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KJJ Cleanser, Root Canal
Device Class -

Regulatory Peers - KJJ Cleanser, Root Canal

All 17
Devices cleared under the same product code (KJJ) and FDA review panel - the closest regulatory comparables to K032627.
CITRIC ACID 20% SOLUTION, MODEL 329
K063703 · Ultradent Products, Inc. · Dec 2006
FILE-EZE
K060335 · Ultradent Products, Inc. · Feb 2006
ENDOPURE ROOT CANAL CLEANSER
K032361 · Dentsply Intl. · Jan 2004
SMEARCLEAR
K024198 · Sybron Dental Specialties, Inc. · Mar 2003
PULPDENT SODIUM HYPOCHLORITE SOLUTION
K962743 · Pulpdent Corp. · Aug 1996
FILE-EZE
K934415 · Ultradent Products, Inc. · Apr 1994