Cleared Traditional

APEX FINDER MODELS 7005 (K962803) - FDA 510(k) Clearance

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
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 45
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