Cleared Special

K113606 - NNC GOLD ABUTMENT FOR BRIDGES
(FDA 510(k) Clearance)

K113606 · Straumann USA · Dental

Jan 2012

Decision

52d

Days

Class 2

Risk

K113606 is an FDA 510(k) clearance for the NNC GOLD ABUTMENT FOR BRIDGES. This device is classified as a Abutment, Implant, Dental, Endosseous (Class II — Special Controls, product code NHA).

Submitted by Straumann USA (Andover, US). The FDA issued a Cleared decision on January 27, 2012, 52 days after receiving the submission on December 6, 2011.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3630. To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation..

Submission Details

510(k) Number	K113606 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 06, 2011
Decision Date	January 27, 2012
Days to Decision	52 days
Submission Type	Special
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.