Cleared Traditional

Neo GBR System (K160991) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K160991 · Neobiotech Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2017
Decision
277d
Days
Class 2
Risk

K160991 is an FDA 510(k) clearance for the Neo GBR System. Classified as Screw, Fixation, Intraosseous (product code DZL), Class II - Special Controls.

Submitted by Neobiotech Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on January 10, 2017 after a review of 277 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4880 - 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 Neobiotech Co., Ltd. devices

Submission Details

510(k) Number K160991 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2016
Decision Date January 10, 2017
Days to Decision 277 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
150d slower than avg
Panel avg: 127d · This submission: 277d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DZL Screw, Fixation, Intraosseous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4880
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 - DZL Screw, Fixation, Intraosseous

All 31
Devices cleared under the same product code (DZL) and FDA review panel - the closest regulatory comparables to K160991.
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SYNTHES (USA) 1.0/1.22 MM CRANIOFACIAL SCREWS
K041887 · Synthes (Usa) · Aug 2004