Cleared Traditional

Dental Implant Abutment OKTAGON Bone Level RC, Dental Implant Abutment OKTAGON Bone Level NC

K160132 · Hager& Meisinger GmbH · Dental

Nov 2016

Decision

306d

Days

Class 2

Risk

About This 510(k) Submission

K160132 is an FDA 510(k) clearance for the Dental Implant Abutment OKTAGON Bone Level RC, Dental Implant Abutment OKTAGON Bone Level NC, a Abutment, Implant, Dental, Endosseous (Class II — Special Controls, product code NHA), submitted by Hager& Meisinger GmbH (Neuss, DE). The FDA issued a Cleared decision on November 21, 2016, 306 days after receiving the submission on January 20, 2016. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K160132 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	NHA — Abutment, Implant, Dental, Endosseous
Device Class	Class II — 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.