Cleared Traditional

Universal Base Abutment

K180899 · Nobel Biocare AB · Dental

Oct 2018

Decision

208d

Days

Class 2

Risk

About This 510(k) Submission

K180899 is an FDA 510(k) clearance for the Universal Base 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 October 31, 2018, 208 days after receiving the submission on April 6, 2018. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K180899 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 06, 2018
Decision Date	October 31, 2018
Days to Decision	208 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.