Cleared Traditional

K962803 - APEX FINDER MODELS 7005

K962803 · Sybron Dental Specialties, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
82d
Days
-
Risk

K962803 is an FDA 510(k) clearance for the APEX FINDER MODELS 7005. Classified as Locator, Root Apex (product code LQY).

Submitted by Sybron Dental Specialties, Inc. (Orange, US). The FDA issued a Cleared decision on October 8, 1996 after a review of 82 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 Sybron Dental Specialties, Inc. devices

Submission Details

510(k) Number K962803 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1996
Decision Date October 08, 1996
Days to Decision 82 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
45d faster than avg
Panel avg: 127d · This submission: 82d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LQY Locator, Root Apex
Device Class -

Regulatory Peers - LQY Locator, Root Apex

All 18
Devices cleared under the same product code (LQY) and FDA review panel - the closest regulatory comparables to K962803.
MULTIPLE (APEX LOCATOR), MODEL RCM-7
K090925 · J. Morita USA, Inc. · Nov 2009
DENTA PORT
K022147 · J. Morita USA, Inc. · Dec 2002
FORAMATRON V, MODEL D680
K002195 · Parkell, Inc. · Aug 2000
ROOT CANAL LENGTH MEASURING DEVICE
K953867 · J. Morita USA, Inc. · Dec 1995
FORAMATRON IV
K950857 · Parkell, Inc. · Apr 1995
PULPDENT CANAL FINDER
K945811 · Pulpdent Corp. · Jan 1995