Cleared Traditional

PULPDENT CANAL FINDER (K945811) - FDA 510(k) Clearance

K945811 · Pulpdent Corp. · Dental device
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Jan 1995
Decision
53d
Days
-
Risk

K945811 is an FDA 510(k) clearance for the PULPDENT CANAL FINDER. Classified as Locator, Root Apex (product code LQY).

Submitted by Pulpdent Corp. (Watertown, US). The FDA issued a Cleared decision on January 20, 1995 after a review of 53 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 K945811 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1994
Decision Date January 20, 1995
Days to Decision 53 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
74d faster than avg
Panel avg: 127d · This submission: 53d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LQY Locator, Root Apex
Device Class -