Cleared Traditional

K052515 - SIROENDO
(FDA 510(k) Clearance)

K052515 · Sirona Dental Systems GmbH · Dental

Mar 2006

Decision

198d

Days

Class 1

Risk

K052515 is an FDA 510(k) clearance for the SIROENDO. This device is classified as a Handpiece, Direct Drive, Ac-powered (Class I — General Controls, product code EKX).

Submitted by Sirona Dental Systems GmbH (N. Attleboro, US). The FDA issued a Cleared decision on March 31, 2006, 198 days after receiving the submission on September 14, 2005.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number	K052515 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 14, 2005
Decision Date	March 31, 2006
Days to Decision	198 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF