Cleared Traditional

K002195 - FORAMATRON V

K002195 · Parkell, Inc. · Dental device
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Aug 2000
Decision
41d
Days
-
Risk

K002195 is an FDA 510(k) clearance for the FORAMATRON V, MODEL D680. Classified as Locator, Root Apex (product code LQY).

Submitted by Parkell, Inc. (Farmingdale, US). The FDA issued a Cleared decision on August 30, 2000 after a review of 41 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 Parkell, Inc. devices

Submission Details

510(k) Number K002195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 2000
Decision Date August 30, 2000
Days to Decision 41 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
86d faster than avg
Panel avg: 127d · This submission: 41d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LQY Locator, Root Apex
Device Class -

Regulatory Peers - LQY Locator, Root Apex

All 19
Devices cleared under the same product code (LQY) and FDA review panel - the closest regulatory comparables to K002195.
RAYPEX 6
K131907 · Dentsply International, Inc. · Jan 2014
MULTIPLE (APEX LOCATOR), MODEL RCM-7
K090925 · J. Morita USA, Inc. · Nov 2009
DENTA PORT
K022147 · J. Morita USA, Inc. · Dec 2002
APEX FINDER MODELS 7005
K962803 · Sybron Dental Specialties, Inc. · Oct 1996
ROOT CANAL LENGTH MEASURING DEVICE
K953867 · J. Morita USA, Inc. · Dec 1995
FORAMATRON IV
K950857 · Parkell, Inc. · Apr 1995