Cleared Traditional

K133592 - NEODENT IMPLANT SYSTEM, TITAMAX TI EX ACQUA AND TI DRIVE ACQUA, TITAMAX SMART EX ACQUA AND DRIVE SMART ACQUA, TITAMAX CM

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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
145d slower than avg
Panel avg: 128d · 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 1523
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K133592.
MPI - MOLECULAR PRECISION IMPLANT, CPI - CYLINDRICAL PRECISION IMPLANT, OPI - ONE PIECE IMPLANT, DENTAL ABUTMENTS AND PR
K140728 · Ditron Precision, Ltd. · Oct 2014
ONE PLUS IMPLANT SYSTEM
K133050 · Osseofuse, Inc. · Sep 2014
AXIOM 2.8
K141450 · Anthogyr Sas · Sep 2014
ZL MICRODENT NATURAL LOCK IMPLANT SYSTEM
K133706 · Zl Microdent-Attachment GmbH & Co. KG · Aug 2014
ANKYLOS C/X IMPLANT SYSTEM
K140347 · Dentsply Intl., Inc. · Aug 2014
STRAUMANN BONE LEVEL TAPERED IMPLANT
K140878 · Straumann USA, LLC · Aug 2014
K133592 · NEODENT IMPLANT SYSTEM, TITAMAX TI EX ACQUA AND TI DRIVE ACQUA, TITAMAX SMART EX ACQUA AND DRIVE SMART ACQUA, TITAMAX CM
Download PDF FDA Summary Neodent USA, Inc.