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 an FDA 510(k) clearance for Signum composite flow, 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 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

FDA 510(k) Submission Details - K240660

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.

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 807
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