Cleared Traditional

K003620 - NSI HEXED AND NON-HEXED IMPLANT SYSTEM

K003620 is an FDA 510(k) clearance for NSI HEXED AND NON-HEXED IMPLANT SYSTEM, manufactured by Nsi. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 301-day FDA review.

K003620 · Nsi · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2001
Decision
301d
Days
Class 2
Risk

K003620 is an FDA 510(k) clearance for the NSI HEXED AND NON-HEXED IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Nsi (Fairfax, US). The FDA issued a Cleared decision on September 19, 2001 after a review of 301 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K003620

510(k) Number K003620 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2000
Decision Date September 19, 2001
Days to Decision 301 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
173d slower than avg
Panel avg: 128d · This submission: 301d
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 1482
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K003620.
QUANTUM VERSATILITY (QVS) DENTAL IMPLANT SYSTEM
K002241 · Quantum Bioengineering, Ltd. · Sep 2001
QUANTUM VERSATILITY (QVS) DENTAL IMPLANT SYSTEM
K011223 · Paxmed International · Sep 2001
QUANTUM VERSATILITY IMPLANT SYSTEM
K991250 · Quantum Bioengineering, Ltd. · Sep 2001
3.25MM SPLINE TWIST IMPLANT
K012055 · Sulzer Dental, Inc. · Sep 2001
ITI DENTAL IMPLANT SYSTEM
K012757 · Straumann USA · Aug 2001
ITI DENTAL IMPLANT SYSTEM
K003552 · Institut Straumann SA · Aug 2001
K003620 · NSI HEXED AND NON-HEXED IMPLANT SYSTEM
Download PDF FDA Summary Nsi