Cleared Traditional

K150909 - INTEGO Family and Accesories

K150909 is an FDA 510(k) clearance for INTEGO Family and Accesories, manufactured by Sirona Dental Systems GmbH. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K150909 · Sirona Dental Systems GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2015
Decision
105d
Days
Class 1
Risk

K150909 is an FDA 510(k) clearance for the INTEGO Family and Accesories. 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 17, 2015 after a review of 105 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

FDA 510(k) Submission Details - K150909

510(k) Number K150909 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2015
Decision Date July 17, 2015
Days to Decision 105 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
22d faster than avg
Panel avg: 127d · This submission: 105d
Pathway characteristics
Predicate-based equivalence.

EIA Device Classification - Class 1, General Controls

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 178
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K150909.
Evogue Dental Unit
K152100 · Takara Belmont Corporation · Jan 2016
Spirit
K143696 · Pelton & Crane · Sep 2015
TENEO Dental Treatment Unit and Accessories
K151045 · Sirona Dental Systems GmbH · Jul 2015
UnicLine Mobile
K150490 · Heka Dental A/S · Apr 2015
Dental Unit
K142206 · Zhuhai Siger Medical Equipment Co., Ltd. · Mar 2015
T-8000 THEROZONE UNIT
K141504 · Therozone USA, Inc. · Feb 2015