Cleared Traditional

K945811 - PULPDENT CANAL FINDER

K945811 · Pulpdent Corp. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K945811

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 128d · This submission: 53d
Pathway characteristics
Predicate-based equivalence.

LQY Device Classification - Class 0,

Product Code LQY Locator, Root Apex
Device Class -

Regulatory Peers - LQY Locator, Root Apex

All 45
Devices cleared under the same product code (LQY) and FDA review panel - the closest regulatory comparables to K945811.
NEOSONO 2000
K955088 · American Medical & Dental Corp. · Jul 1996
ROOT CANAL LENGTH MEASURING DEVICE
K953867 · J. Morita USA, Inc. · Dec 1995
FORAMATRON IV
K950857 · Parkell, Inc. · Apr 1995
ROOT ZX
K921979 · J. Morita USA, Inc. · May 1993
OSADA ENDEX
K904742 · Osada Electric Co., Ltd. · Dec 1990
COATED APEX PROBE
K890735 · Analytic Technology · Apr 1989
K945811 · PULPDENT CANAL FINDER
Download PDF FDA Summary Pulpdent Corp.