Cleared Traditional

K111357 - STRAUMANN NARROW NECK CROSSFIT (NNC) 03.3MM DENTAL IMPLANT SYSTEM
(FDA 510(k) Clearance)

K111357 · Straumann USA · Dental

Oct 2011

Decision

140d

Days

Class 2

Risk

K111357 is an FDA 510(k) clearance for the STRAUMANN NARROW NECK CROSSFIT (NNC) 03.3MM DENTAL IMPLANT SYSTEM. This device is classified as a Implant, Endosseous, Root-form (Class II — Special Controls, product code DZE).

Submitted by Straumann USA (Andover, US). The FDA issued a Cleared decision on October 3, 2011, 140 days after receiving the submission on May 16, 2011.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number	K111357 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 16, 2011
Decision Date	October 03, 2011
Days to Decision	140 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF