Cleared Traditional

K230644 - Signum opaque F

K230644 is an FDA 510(k) clearance for Signum opaque F, manufactured by Kulzer, LLC. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K230644 · Kulzer, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2023
Decision
183d
Days
Class 2
Risk

K230644 is an FDA 510(k) clearance for the Signum opaque F. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Kulzer, LLC (South Bend, US). The FDA issued a Cleared decision on September 7, 2023 after a review of 183 days - an extended review cycle.

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

FDA 510(k) Submission Details - K230644

510(k) Number K230644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2023
Decision Date September 07, 2023
Days to Decision 183 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d slower than avg
Panel avg: 127d · This submission: 183d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 650
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