# K041960: Composite/Compomer Repair Kit

- Pathway: 510(k) (Abbreviated)
- Applicant: Dmg USA, Inc.
- Decided: Aug 30, 2004 after 40 days
- Product code: KLE (Agent, Tooth Bonding, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K931812 (1993). 31 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002086: Primaflow, Dmg USA, Inc. (2000) Summary page 1.
- K970683: Zentih Flowable Composite (Multiple), Foremost Dental Mfg., Inc. (1997) Summary page 1.
- K992879: Ecusit Composite Repair, Dmg Hamburg (1999) Summary page 1.
- K001914: Clearfil Repair, Kuraray Company, Ltd. (2000) Summary page 1.
- K012316: Permacem / Permacem Dual, Dmg USA, Inc. (2001) Summary page 1.
- K012307: Luxacore/Luxacore Dual, Dmg USA, Inc. (2001) Summary page 1.
- K003153: Solobond Plus, Voco GmbH (2000) Summary page 1.
- K845033: Foremost Dentin Adhesive, Foremost Dental Mfg., Inc. (1985) Summary page 1.
- K023776: Xeno Iii Dental Adhesive, Dentsply Intl. (2003) Summary page 1.
- K022612: Ibond Gluma Inside, Heraeus Kulzer, Inc. (2002) Summary page 1.

## Most influential descendants
- K063444: Total Etch Bonding Agent (2007), 0 descendants of its own

## Indications for use
The Composite/Compomer Repair Kit consists of 4 materials: 1. a general 6t h generation bonding agent for enamel and dentin, 2. a special bonding agent for resin-based materials in general, i. e. composites, compomers, and ormocers, 3. a flowable compomer and 4. a flowable composite Bonding System (Contax) is indicated for • bonding chemically cured, light cured, or dual cured resin-based materials e. g. composite, compomer, ormocer materials to tooth structure (dentin and enamel) • treatment of hypersensitive teeth Composite Repair MMA-free is indicated as a bonding agent for the intra- or extraoral repair of poor or damaged resin-based materials restorations • as a bonding agent for composite-based posts • for shade corrections of esthetically unsatisfying restorations • for repair and completion of temporary crowns and bridges • as a bonding agent on resin-based materials PrimaFlow is indicated for • minimally invasive restorations • Class III and V restorations • bases • extended fissure sealing • restorations of all classes of cavities in deciduous teeth • as a temporary luting cement for e.g. veneers, and • as a flowable compomer repair agent Flowable Composite (LuxaFlow) is indicated as • as an aesthetic anterior restoration • a base restoration under posterior or anterior composites • an add-on or repair material for provisional crowns & bridges • for incorporation of most mechanically anchored attachment components into the acrylic base of an overdenture or partial denture. • as a temporary luting cement for e.g. veneers, and • as a flowable composite repair agent

Source page: https://510kreport.com/device/K041960
Methodology: https://510kreport.com/methodology