Cleared Traditional

K181110 - PROPHYflex 4

K181110 is the FDA 510(k) clearance for PROPHYflex 4 by Kaltenbach & Voigt GmbH. It is a Class 1 Dental device (product code EFB) cleared through the Traditional 510(k) pathway after a 348-day FDA review.

K181110 · Kaltenbach & Voigt GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2019
Decision
348d
Days
Class 1
Risk

K181110 is an FDA 510(k) clearance for the PROPHYflex 4. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Kaltenbach & Voigt GmbH (Biberach, DE). The FDA issued a Cleared decision on April 10, 2019 after a review of 348 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - 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. Elevated predicate reliance profile. 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

Submission Details

510(k) Number K181110 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2018
Decision Date April 10, 2019
Days to Decision 348 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
221d slower than avg
Panel avg: 127d · This submission: 348d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFB Handpiece, Air-powered, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
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

Kavo Dental Technologies, LLC
Frank Ray

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 - EFB Handpiece, Air-powered, Dental

All 66
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