Cleared Traditional

K033171 - NSI HEXED AND NON-HEXED IMPLANT SYSTEM AND IMMEDIATE LOADING

K033171 is an FDA 510(k) clearance for NSI HEXED AND NON-HEXED IMPLANT SYSTEM ..., manufactured by Northern Implants, LLC. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K033171 · Northern Implants, LLC · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
210d
Days
Class 2
Risk

K033171 is an FDA 510(k) clearance for the NSI HEXED AND NON-HEXED IMPLANT SYSTEM AND IMMEDIATE LOADING. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Northern Implants, LLC (Fairfax, US). The FDA issued a Cleared decision on April 27, 2004 after a review of 210 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K033171

510(k) Number K033171 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2003
Decision Date April 27, 2004
Days to Decision 210 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
82d slower than avg
Panel avg: 128d · This submission: 210d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZE Device Classification - Class 2, Special Controls

Product Code DZE Implant, Endosseous, Root-form
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - DZE Implant, Endosseous, Root-form

All 1529
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K033171.
MIS DENTAL IMPLANT SYSTEM
K040807 · Mis - Implant Technologies , Ltd. · Jun 2004
KLS MARTIN ORTHO ANCHORAGE SYSTEM (PLATES)
K040891 · KLS-Martin L.P. · May 2004
LORENZ SELF-DRILLING IMF SCREW
K040983 · Walter Lorenz Surgical, Inc. · May 2004
LOCATOR BAR FEMALE, LOCATOR LASER BAR FEMALE, LOCATOR BAR CAST-TO FEMALE, MODELS 08587, 08588, 08586
K033699 · Zest Anchors, Inc. · Apr 2004
MODIFICATION OF: SPHERO FLEX, PIVOT FLEX, AND SPHERO BLOCK
K033630 · Rhein 83 Srl · Apr 2004
HYBRID ENDOPORE ENDOSSEOUS DENTAL IMPLANT
K040714 · Innova Corp. · Apr 2004
K033171 · NSI HEXED AND NON-HEXED IMPLANT SYSTEM AND IMMEDIATE LOADING
Download PDF FDA Summary Northern Implants, LLC