Cleared Traditional

K160221 - Implance Dental Implant System

K160221 is an FDA 510(k) clearance for Implance Dental Implant System, manufactured by Ags Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 227-day FDA review.

K160221 · Ags Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
227d
Days
Class 2
Risk

K160221 is an FDA 510(k) clearance for the Implance Dental Implant System, Implance Dental Abutment System. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Ags Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti. (Istanbul, TR). The FDA issued a Cleared decision on September 12, 2016 after a review of 227 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 Ags Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti. devices

FDA 510(k) Submission Details - K160221

510(k) Number K160221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2016
Decision Date September 12, 2016
Days to Decision 227 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
100d slower than avg
Panel avg: 127d · This submission: 227d
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 821
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K160221.
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s-Clean Tapered II RBM Implant System
K160213 · Dentis Co., Ltd. · Jun 2016