Cleared Traditional

K110580 - NARROW CONNECTION STRAUMANN ANATOMIC IPS E.MAX ABUTMENTS
(FDA 510(k) Clearance)

K110580 · Straumann USA · Dental

Aug 2011

Decision

164d

Days

Class 2

Risk

K110580 is an FDA 510(k) clearance for the NARROW CONNECTION STRAUMANN ANATOMIC IPS E.MAX ABUTMENTS. 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 August 12, 2011, 164 days after receiving the submission on March 1, 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	K110580 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 01, 2011
Decision Date	August 12, 2011
Days to Decision	164 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.