Cleared Abbreviated

K091635 - VENUS DIAMOND FLOW

K091635 is an FDA 510(k) clearance for VENUS DIAMOND FLOW, manufactured by Heraeus Kulzer, LLC. The device is a Class 2 Dental device with product code EBF cleared through the Abbreviated 510(k) pathway after a 91-day FDA review.

K091635 · Heraeus Kulzer, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2009
Decision
91d
Days
Class 2
Risk

K091635 is an FDA 510(k) clearance for the VENUS DIAMOND FLOW. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Heraeus Kulzer, LLC (South Bend, US). The FDA issued a Cleared decision on September 3, 2009 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 Heraeus Kulzer, LLC devices

FDA 510(k) Submission Details - K091635

510(k) Number K091635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2009
Decision Date September 03, 2009
Days to Decision 91 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
36d faster than avg
Panel avg: 127d · This submission: 91d
Pathway characteristics
Standards-based clearance path.

EBF Device Classification - Class 2, Special Controls

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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.

Regulatory Peers - EBF Material, Tooth Shade, Resin

All 696
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