Cleared Traditional

K133592 - NEODENT IMPLANT SYSTEM

K133592 is an FDA 510(k) clearance for NEODENT IMPLANT SYSTEM, manufactured by Neodent USA, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 273-day FDA review.

K133592 · Neodent USA, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2014
Decision
273d
Days
Class 2
Risk

K133592 is an FDA 510(k) clearance for the NEODENT IMPLANT SYSTEM, TITAMAX TI EX ACQUA AND TI DRIVE ACQUA, TITAMAX SMART.... Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Neodent USA, Inc. (Andover, US). The FDA issued a Cleared decision on August 22, 2014 after a review of 273 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.

View all Neodent USA, Inc. devices

FDA 510(k) Submission Details - K133592

510(k) Number K133592 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2013
Decision Date August 22, 2014
Days to Decision 273 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
146d slower than avg
Panel avg: 127d · This submission: 273d
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 840
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K133592.
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