Cleared Traditional

K083550 - STRAUMANN DENTAL IMPLANT SYSTEM
(FDA 510(k) Clearance)

K083550 · Straumann USA · Dental

Feb 2009

Decision

87d

Days

Class 2

Risk

K083550 is an FDA 510(k) clearance for the STRAUMANN 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 February 26, 2009, 87 days after receiving the submission on December 1, 2008.

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

Submission Details

510(k) Number	K083550 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 01, 2008
Decision Date	February 26, 2009
Days to Decision	87 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF