Cleared Traditional

K120792 - TIXOS IMPLANT SYSTEM

K120792 is an FDA 510(k) clearance for TIXOS IMPLANT SYSTEM, manufactured by Leader Italia S.R.L.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K120792 · Leader Italia S.R.L. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2012
Decision
174d
Days
Class 2
Risk

K120792 is an FDA 510(k) clearance for the TIXOS IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Leader Italia S.R.L. (Austin, US). The FDA issued a Cleared decision on September 5, 2012 after a review of 174 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 - K120792

510(k) Number K120792 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2012
Decision Date September 05, 2012
Days to Decision 174 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
46d slower than avg
Panel avg: 128d · This submission: 174d
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 1484
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K120792.
LEW MDI O-BALL COLLARED IMPLANT,
K121707 · Park Dental Research Corp. · Sep 2012
B&W DENTAL IMPLANT SYSTEM
K120875 · B&W Srl · Sep 2012
NEOSS PROACTIVE TAPERED IMPLANT
K113376 · Neoss, Ltd. · Sep 2012
BIOHORIZONS TAPERED INTERNAL PLUS IMPLANTS
K121787 · BioHorizons Implant Systems, Inc. · Sep 2012
ZIMMER DENTAL TAPERED SCREW-VENT X
K113753 · Zimmer Dental, Inc. · Aug 2012
ET/SS IMPLANT SYSTEM
K120847 · Osstem Implant Co., Ltd. · Aug 2012
K120792 · TIXOS IMPLANT SYSTEM
Download PDF FDA Summary Leader Italia S.R.L.