# K240660: Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-active

- Pathway: 510(k) (Traditional)
- Applicant: Kulzer, LLC
- Decided: Sep 17, 2024 after 193 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K902115 (1990). 19 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961434: Vita Zeta Crown and Bridge Acrylic Veneering System, Vident (1996) Summary page 6.
- K152373: VITA VM LC Flow, Vita Zahnfabrik H.Rauter GmbH & Co. (2015) Summary page 6.
- K211854: VITA Akzent LC, Vita Zahnfabrik GmbH H Rauter & CO (2021) Summary page 6.

## Most influential descendants
- K251587: VITA VMLC Primer (2026), 0 descendants of its own

## Indications for use
Signum metal bond: - Bonding agent between framework surfaces made of metal alloys (precious metal, non-precious metal or titanium) and (meth-) acrylate-based veneering materials in conjunction with micromechanical retention. - Bonding agent between partial framework surfaces made of metal alloys (precious metal, non-precious metal or titanium) and (meth-) acrylate-based veneering materials or denture base materials (hot or auto-polymerizates). - Bonding agent for extraoral repair of metal supported composite veneers. Signum universal bond: Metal - Bonding agent between framework surfaces made of metal alloys (precious metal, non-precious metal or titanium) and (meth-) acrylate-based veneering materials in conjunction with macro-mechanical retentions. - Bonding agent between partial framework surfaces made of metal alloys (precious metal, non-precious metal or titanium) and (meth-) acrylate-based veneering materials or denture base materials (hot or auto-polymerizates). - Bonding agent for the extraoral repair of metal-supported composite veneers. Zirconium dioxide - Bonding agent between frameworks, implant abutments and single crowns made of ZrO2 and light-curing veneering materials. - Bonding agent for the extraoral repair of composite veneers on ZrO2 frameworks. High performance polymers (PEEK) - Bonding agent between frameworks, implant abutments and individual crowns made of high performance polymers and light-curing veneering materials. - Bonding agent between partial framework surfaces made of high-performance polymers and light-curing veneering materials or denture base materials (hot or auto-polymerizate). - Bonding agent for the extraoral repair of composite veneers on PEEK frameworks. Signum liquid: For light-curing veneering materials from Kulzer: - Restoring the dispersion layer of light curing veneering materials. Signum composite / Signum composite flow / Signum matrix: Suitable for veneering the following dental framework materials: Metal alloys (precious metal, non-precious or titanium), zirconia, high-performance polymers (PEEK) Suitable for partial alteration of the colour and shape of the following dental materials: •PMMA •Photopolymers Suitable for the following prosthetic restorations: •full and partial veneers for permanent framework-supported crowns and bridges • veneering removable combination prosthetics (telescopic and tapered crowns and at-tachment prosthetics) • veneering of superstructures/tertiary structures on implants • metal-free front tooth and posterior tooth temporary restorations • alteration of the colour and shape of Kulzer acrylic denture teeth • alteration of the colour and shape of acrylic-based frameworks (PMMA). • alteration of the colour and shape of Kulzer photopolymers that are approved for char-acterisation with Signum components (according to the photopolymer instructions for use) Signum ere-active: Individual characterization (e.g., of enamel cracks, white spots, imitation fillings, enamel wedges, intermediate colour layers, abrasion surfaces, fissures) of •light-curing Kulzer veneering materials, • Kulzer denture acrylic teeth and PMMA, • (meth-)acrylate-based 3D printing photopolymers in accordance with the photopolymer instructions for use

Source page: https://510kreport.com/device/K240660
Methodology: https://510kreport.com/methodology