Cleared Traditional

K160850 - Nucleoss Tpure Implant System

K160850 is an FDA 510(k) clearance for Nucleoss Tpure Implant System, manufactured by Sanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 494-day FDA review.

K160850 · Sanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2017
Decision
494d
Days
Class 2
Risk

K160850 is an FDA 510(k) clearance for the Nucleoss Tpure Implant System. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Sanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti (Bolgesi Tekeli, TR). The FDA issued a Cleared decision on August 4, 2017 after a review of 494 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Sanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti devices

FDA 510(k) Submission Details - K160850

510(k) Number K160850 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2016
Decision Date August 04, 2017
Days to Decision 494 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
367d slower than avg
Panel avg: 127d · This submission: 494d
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 K160850.
Thommen Implant System
K171795 · Thommen Medical AG · Sep 2017
Implantium II
K171126 · Dentium Co., Ltd. · Sep 2017
Dentis Dental Implant System
K171027 · Dentis Co., Ltd. · Sep 2017
Neodent Implant System - GM Line
K163194 · Jjgc Industria E Comercio DE Materiais Dentarios S.A. · Jul 2017
Deep Conical (DC) Implants and Accessories
K163060 · Southern Implants (Pty), Ltd. · Jun 2017
MRI Compatibility for Existing Zimmer Dental Implant Systems
K160398 · Zimmer Dental, Inc. · May 2017