Cleared Traditional

K151045 - TENEO Dental Treatment Unit and Accesso...

K151045 is the FDA 510(k) clearance for TENEO Dental Treatment Unit and Accesso... by Sirona Dental Systems GmbH. It is a Class 1 Dental device (product code EIA) cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K151045 · Sirona Dental Systems GmbH · Dental device
Download Printable Device Report (PDF)
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Jul 2015
Decision
95d
Days
Class 1
Risk

K151045 is an FDA 510(k) clearance for the TENEO Dental Treatment Unit and Accessories. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Sirona Dental Systems GmbH (Bensheim, DE). The FDA issued a Cleared decision on July 24, 2015 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Sirona Dental Systems GmbH devices

Submission Details

510(k) Number K151045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 127d · This submission: 95d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EIA Unit, Operative Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Consultant

Sirona Dental Systems, Inc.
KOFI ANINAKWA

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EIA Unit, Operative Dental

All 60
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