Cleared Traditional

K962743 - PULPDENT SODIUM HYPOCHLORITE SOLUTION

K962743 · Pulpdent Corp. · Dental device

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Aug 1996

Decision

22d

Days

Risk

K962743 is an FDA 510(k) clearance for the PULPDENT SODIUM HYPOCHLORITE SOLUTION. Classified as Cleanser, Root Canal (product code KJJ).

Submitted by Pulpdent Corp. (Watertown, US). The FDA issued a Cleared decision on August 6, 1996 after a review of 22 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 Pulpdent Corp. devices

Submission Details

510(k) Number	K962743 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 15, 1996
Decision Date	August 06, 1996
Days to Decision	22 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

105d faster than avg

Panel avg: 127d · This submission: 22d

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 K962743.

ENDOPURE ROOT CANAL CLEANSER

K032361 · Dentsply Intl. · Jan 2004

ULTRADENT CITRIC ACID 10% SOLUTION

K032627 · Ultradent Products, Inc. · Nov 2003

SMEARCLEAR

K024198 · Sybron Dental Specialties, Inc. · Mar 2003

FILE-EZE

K934415 · Ultradent Products, Inc. · Apr 1994

CLEANSER, ROOT CANAL

K802853 · Dentsply Intl. · Dec 1980

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K962743

Pulpdent Corp.

Watertown, MA · US

KENNETH J BERK

Regulatory profile

78 submissions 78 cleared

100% clearance rate · Active in Dental

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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