Cleared Traditional

Dental Implants OKTAGON Bone Level Tapered Design (K170287) - FDA 510(k) Clearance

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

K170287 · Hager& Meisinger GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2017
Decision
114d
Days
Class 2
Risk

K170287 is an FDA 510(k) clearance for the Dental Implants OKTAGON Bone Level Tapered Design. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Hager& Meisinger GmbH (Neuss, DE). The FDA issued a Cleared decision on May 24, 2017 after a review of 114 days - within the typical 510(k) review window.

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 Hager& Meisinger GmbH devices

Submission Details

510(k) Number K170287 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2017
Decision Date May 24, 2017
Days to Decision 114 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
13d faster than avg
Panel avg: 127d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 305
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K170287.
SPI Dental Implant System
K172240 · Msi France · Jan 2018
Straumann Dental Implant System
K171784 · Straumann USA, LLC · Jan 2018
TREFOIL System
K172352 · Nobel Biocare AB · Oct 2017
TREFOIL System
K170135 · Nobel Biocare AB · May 2017
NobelZygoma 0°
K161598 · Nobel Biocare AB · Mar 2017
GC AADVA IMPLANT SYSTEM
K093749 · GC America, Inc. · Dec 2010