Cleared Traditional

K161488 - ESTETICA Dental Treatment Unit and Accessories

K161488 is an FDA 510(k) clearance for ESTETICA Dental Treatment Unit and Acce..., manufactured by Kaltenbach & Voigt GmbH. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K161488 · Kaltenbach & Voigt GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2016
Decision
190d
Days
Class 1
Risk

K161488 is an FDA 510(k) clearance for the ESTETICA Dental Treatment Unit and Accessories. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Kaltenbach & Voigt GmbH (Biberach, DE). The FDA issued a Cleared decision on December 8, 2016 after a review of 190 days - an extended review cycle.

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 Kaltenbach & Voigt GmbH devices

FDA 510(k) Submission Details - K161488

510(k) Number K161488 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2016
Decision Date December 08, 2016
Days to Decision 190 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
63d slower than avg
Panel avg: 127d · This submission: 190d
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.

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