Cleared Traditional

Z5m(t) (K150021) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 305
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K150021.
TREFOIL System
K172352 · Nobel Biocare AB · Oct 2017
TREFOIL System
K170135 · Nobel Biocare AB · May 2017
NobelZygoma 0°
K161598 · Nobel Biocare AB · Mar 2017
GC AADVA IMPLANT SYSTEM
K093749 · GC America, Inc. · Dec 2010
JNE IMPLANT SYSTEM
K072425 · GC America, Inc. · Mar 2008
DENTSPLY PRECISION TORQUE SYSTEM
K964046 · Dentsply Intl. · Mar 1997