Cleared Traditional

K143539 - Dental Implant OKTAGON Bone Level

K143539 is an FDA 510(k) clearance for Dental Implant OKTAGON Bone Level, 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 259-day FDA review.

K143539 · Hager& Meisinger GmbH · Dental device
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Aug 2015
Decision
259d
Days
Class 2
Risk

K143539 is an FDA 510(k) clearance for the Dental Implant OKTAGON Bone Level. 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 August 31, 2015 after a review of 259 days - an extended review cycle.

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 - K143539

510(k) Number K143539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2014
Decision Date August 31, 2015
Days to Decision 259 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
131d slower than avg
Panel avg: 128d · This submission: 259d
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 K143539.
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