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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
366d slower than avg
Panel avg: 128d · 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 Consultant

Registrar Corp.
H.Semih Oktay

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DZE Implant, Endosseous, Root-form

All 1424
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K160850.
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