Cleared Traditional

K160132 - Dental Implant Abutment OKTAGON Bone Le...

K160132 is an FDA 510(k) clearance for Dental Implant Abutment OKTAGON Bone Le..., manufactured by Hager& Meisinger GmbH. The device is a Class 2 Dental device with product code NHA cleared through the Traditional 510(k) pathway after a 306-day FDA review.

K160132 · Hager& Meisinger GmbH · Dental device
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Nov 2016
Decision
306d
Days
Class 2
Risk

K160132 is an FDA 510(k) clearance for the Dental Implant Abutment OKTAGON Bone Level RC, Dental Implant Abutment OKTAGO.... Classified as Abutment, Implant, Dental, Endosseous within the NHA classification (a category for dental implant abutments and prosthetic components), Class II - Special Controls.

Submitted by Hager& Meisinger GmbH (Neuss, DE). The FDA issued a Cleared decision on November 21, 2016 after a review of 306 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3630 - 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.

View all Hager& Meisinger GmbH devices

FDA 510(k) Submission Details - K160132

510(k) Number K160132 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 2016
Decision Date November 21, 2016
Days to Decision 306 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
179d slower than avg
Panel avg: 127d · This submission: 306d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NHA Device Classification - Class 2, Special Controls

Product Code NHA Abutment, Implant, Dental, Endosseous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3630
Definition To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation.
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 - NHA Abutment, Implant, Dental, Endosseous

All 534
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