Cleared Traditional

K131701 - Z5MLB

K131701 is an FDA 510(k) clearance for Z5MLB, 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 86-day FDA review.

K131701 · Z-Systems AG · Dental device
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Sep 2013
Decision
86d
Days
Class 2
Risk

K131701 is an FDA 510(k) clearance for the Z5MLB, Z5MLC. 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 September 5, 2013 after a review of 86 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Z-Systems AG devices

FDA 510(k) Submission Details - K131701

510(k) Number K131701 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2013
Decision Date September 05, 2013
Days to Decision 86 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
41d faster than avg
Panel avg: 127d · This submission: 86d
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 K131701.
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