Cleared Traditional

K240660 - Signum composite flow

Also marketed or referenced as:
Signum universal bond Signum metal bond Signum composite Signum matrix Signum liquid Signum cre-active

K240660 is the FDA 510(k) clearance for Signum composite flow by Kulzer, LLC. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K240660 · Kulzer, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2024
Decision
193d
Days
Class 2
Risk

K240660 is an FDA 510(k) clearance for the Signum composite flow. 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 17, 2024 after a review of 193 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

Submission Details

510(k) Number K240660 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2024
Decision Date September 17, 2024
Days to Decision 193 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
66d slower than avg
Panel avg: 127d · This submission: 193d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 612
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K240660.
Jet Flow Bulk
K242014 · Meta Biomed Co., Ltd. · Oct 2024
Crown HT
K242277 · Sprintray, Inc. · Oct 2024
Any-Com
K241147 · Mediclus Co., Ltd. · Sep 2024
C&B NFH Hybrid
K232559 · Arum Dentistry Co., Ltd. · Sep 2024
els extra low shrinkage® composite & els extra low shrinkage® flow
K240823 · Saremco Dental AG · Jun 2024
Temporis, Irix Plus
K231142 · Dws S.R.L. · Apr 2024