Cleared Traditional

K150021 - Z5m(t)

K150021 is an FDA 510(k) clearance for Z5m(t), manufactured by Z-Systems AG. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 206-day FDA review.

K150021 · Z-Systems AG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2015
Decision
206d
Days
Class 2
Risk

K150021 is an FDA 510(k) clearance for the Z5m(t). Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Z-Systems AG (Oensingen, CH). The FDA issued a Cleared decision on July 31, 2015 after a review of 206 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 Z-Systems AG devices

FDA 510(k) Submission Details - K150021

510(k) Number K150021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 2015
Decision Date July 31, 2015
Days to Decision 206 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
79d slower than avg
Panel avg: 127d · This submission: 206d
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 767
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K150021.
NobelZygoma 45°
K152093 · Nobel Biocare AB · Mar 2016
PURE Ceramic Implants
K151328 · Straumann USA · Jan 2016
OneQ-SL Implant System
K142313 · Dentis Co., Ltd. · Dec 2015
Dentis Dental Implant System
K150344 · Dentis Co., Ltd. · Jul 2015
Straumann® Dental Implant System ¿ Roxolid® SLA Implants
K150938 · Straumann USA, LLC · Jul 2015
MiNi Internal Implant System
K150537 · Megagen Implant Co., Ltd. · Jul 2015