Cleared Traditional

K162299 - Spiral Shape Dental Implant System

K162299 is an FDA 510(k) clearance for Spiral Shape Dental Implant System, manufactured by Gp Implants. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 310-day FDA review.

K162299 · Gp Implants · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2017
Decision
310d
Days
Class 2
Risk

K162299 is an FDA 510(k) clearance for the Spiral Shape Dental Implant System. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Gp Implants (Netanya, IL). The FDA issued a Cleared decision on June 22, 2017 after a review of 310 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K162299

510(k) Number K162299 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2016
Decision Date June 22, 2017
Days to Decision 310 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
182d slower than avg
Panel avg: 128d · This submission: 310d
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 1424
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K162299.
Bonafix TWO - Dental Implant System
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SpiralTech Dental Implant System
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K163060 · Southern Implants (Pty), Ltd. · Jun 2017
MIS V3 Conical Connection Dental Implant System­
K163349 · Mis Implants Technologies , Ltd. · May 2017