Cleared Traditional

K132881 - Z5C

K132881 is an FDA 510(k) clearance for Z5C, 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 293-day FDA review.

K132881 · Z-Systems AG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2014
Decision
293d
Days
Class 2
Risk

K132881 is an FDA 510(k) clearance for the Z5C. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Z-Systems AG (San Diego, US). The FDA issued a Cleared decision on July 3, 2014 after a review of 293 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 - K132881

510(k) Number K132881 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2013
Decision Date July 03, 2014
Days to Decision 293 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
166d slower than avg
Panel avg: 127d · This submission: 293d
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 K132881.
HIOSSEN IMPLANT SYSTEM
K140934 · Hiossen, Inc. · Nov 2014
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K142082 · Zimmer Dental, Inc. · Oct 2014
STRAUMANN BONE LEVEL TAPERED IMPLANT
K140878 · Straumann USA, LLC · Aug 2014
NOBELACTIVE WIDE PLATFORM (WP)
K133731 · Nobel Biocare AB · May 2014
ZIMMER DENTAL TAPERED SCREW VENT T IMPLANT, HA COATED
K133339 · Zimmer Dental, Inc. · Mar 2014
ZIMMER DENTAL TRABECULAR METAL IMPLANT SYSTEM
K132258 · Zimmer Dental, Inc. · Nov 2013