Cleared Abbreviated

K171562 - Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono (FDA 510(k) Clearance)

Class II Dental device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K171562 · Dreve Dentamid GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2018
Decision
318d
Days
Class 2
Risk

K171562 is an FDA 510(k) clearance for the Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Dreve Dentamid GmbH (Unna, DE). The FDA issued a Cleared decision on April 13, 2018 after a review of 318 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3660 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Dreve Dentamid GmbH devices

Submission Details

510(k) Number K171562 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2017
Decision Date April 13, 2018
Days to Decision 318 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
191d slower than avg
Panel avg: 127d · This submission: 318d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code ELW Material, Impression
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3660
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

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