Cleared Traditional

On1 Universal Abutment

K181869 · Nobel Biocare AB · Dental

Dec 2018

Decision

153d

Days

Class 2

Risk

About This 510(k) Submission

K181869 is an FDA 510(k) clearance for the On1 Universal Abutment, a Abutment, Implant, Dental, Endosseous (Class II — Special Controls, product code NHA), submitted by Nobel Biocare AB (Goteborg, SE). The FDA issued a Cleared decision on December 12, 2018, 153 days after receiving the submission on July 12, 2018. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K181869 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 12, 2018
Decision Date	December 12, 2018
Days to Decision	153 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.