Cleared Traditional

K170287 - Dental Implants OKTAGON Bone Level Tapered Design

K170287 is an FDA 510(k) clearance for Dental Implants OKTAGON Bone Level Tape..., manufactured by Hager& Meisinger GmbH. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 114-day FDA review.

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

FDA 510(k) Submission Details - K170287

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 128d · This submission: 114d
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 1369
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K170287.
Axiom PX
K161177 · Anthogyr Sas · Jun 2017
Deep Conical (DC) Implants and Accessories
K163060 · Southern Implants (Pty), Ltd. · Jun 2017
MIS V3 Conical Connection Dental Implant System­
K163349 · Mis Implants Technologies , Ltd. · May 2017
MRI Compatibility for Existing Zimmer Dental Implant Systems
K160398 · Zimmer Dental, Inc. · May 2017
SS SA Fixture
K163557 · Osstem Implant Co., Ltd. · May 2017
TREFOIL System
K170135 · Nobel Biocare AB · May 2017