Cleared Traditional

TENEO Dental Treatment Unit and Accessories

K151045 · Sirona Dental Systems GmbH · Dental
Jul 2015
Decision
95d
Days
Class 1
Risk

About This 510(k) Submission

K151045 is an FDA 510(k) clearance for the TENEO Dental Treatment Unit and Accessories, a Unit, Operative Dental (Class I — General Controls, product code EIA), submitted by Sirona Dental Systems GmbH (Bensheim, DE). The FDA issued a Cleared decision on July 24, 2015, 95 days after receiving the submission on April 20, 2015. This device falls under the Dental review panel. Regulated under 21 CFR 872.6640.

Submission Details

510(k) Number K151045 FDA.gov
FDA Decision Cleared SESE
Date Received April 20, 2015
Decision Date July 24, 2015
Days to Decision 95 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EIA — Unit, Operative Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.6640

Similar Devices — EIA Unit, Operative Dental

All 283
Midmark Dental Delivery System
K251626 · Midmark Corporation · Nov 2025
K5 Cart, K5 Mount, K5 Swing
K251491 · Osstem Implant Company., Ltd. Chair Business · Jul 2025
Integral Dental Unit
K243130 · Guangdong Yadeng Medical Apparatus Co., Ltd., · Jun 2025
Integral Dental Units
K242611 · Mipont Medical Equipment Co., Ltd. · May 2025
Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus
K250473 · Dci International, LLC · Feb 2025
BDC Dental Unit
K242404 · Bdc Dental Corporation , Ltd. · Feb 2025