Cleared Traditional

K240660 - Signum composite flow (FDA 510(k) Clearance)

Also includes:
Signum universal bond Signum metal bond Signum composite Signum matrix Signum liquid Signum cre-active

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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 926
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K240660.
Dura-Crown
K261356 · Hangzhou SHINING3D Dental Technology Co., Ltd. · Apr 2026
Grandio disc multicolor
K261357 · Voco GmbH · Apr 2026
Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT)
K260152 · Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda. · Apr 2026
Light-curing Coloring Materials (ALCM)
K253036 · Aidite (Qinhuangdao) Technology Co., Ltd. · Apr 2026
Venus Diamond
K260783 · Kulzer, LLC · Mar 2026
ZAFIRA®
K254245 · New Stetic, SA · Mar 2026