Cleared Traditional

K082532 - STRAUMANN GUIDED INSTRUMENTS
(FDA 510(k) Clearance)

K082532 · Straumann USA · Dental

Oct 2008

Decision

49d

Days

Class 2

Risk

K082532 is an FDA 510(k) clearance for the STRAUMANN GUIDED INSTRUMENTS. This device is classified as a Drill, Bone, Powered (Class II — Special Controls, product code DZI).

Submitted by Straumann USA (Andover, US). The FDA issued a Cleared decision on October 21, 2008, 49 days after receiving the submission on September 2, 2008.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4120.

Submission Details

510(k) Number	K082532 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 02, 2008
Decision Date	October 21, 2008
Days to Decision	49 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF