Cleared Traditional

Healing Cap Multi-Unit Titanium

K171142 · Nobel Biocare AB · Dental

Oct 2017

Decision

191d

Days

Class 2

Risk

About This 510(k) Submission

K171142 is an FDA 510(k) clearance for the Healing Cap Multi-Unit Titanium, 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 26, 2017, 191 days after receiving the submission on April 18, 2017. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K171142 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 18, 2017
Decision Date	October 26, 2017
Days to Decision	191 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.