Futurabond Dc/Single Dose
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by VOCO GmbH
Identifiers
- 510(k) Number
- K070723 FDA 510(k)
- FDA Product Code
- KLE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3200 FDA 510(k)
- Regulation Number
- 872.3200 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Futurabond DC Single Dose is a resin-based dental adhesive classified as an Agent, Tooth Bonding. It is designed to bond dental restorations, such as composites and ceramics, to tooth structure by creating a durable mechanical and chemical bond. This adhesive ensures long-term retention of restorative materials while maintaining the integrity of the dental substrate.
The device is supplied as a single-dose unit, intended for use in dental clinics and offices. It is classified as a Class II medical device under the Medical Device Regulation (MDR) and has received FDA 510(k) clearance as substantially equivalent to a predicate device. Futurabond DC Single Dose is non-sterile and intended for single-use only, adhering to standard dental practice protocols. No MRI safety information is specified, and storage should follow manufacturer guidelines to preserve efficacy.
Frequently asked questions
What is the primary purpose of Futurabond DC Single Dose in dental procedures?
Futurabond DC Single Dose is designed specifically to bond dental restorations—such as composites and ceramics—to tooth structure. It creates a durable mechanical and chemical bond, ensuring long-term retention of restorative materials while preserving the integrity of the natural tooth.
How is Futurabond DC Single Dose supplied, and is it intended for single-use?
The adhesive is supplied as a single-dose unit, meaning each package contains one use only. This aligns with standard dental practice protocols, where single-use adhesives minimize cross-contamination risks and ensure optimal performance per application.
Is Futurabond DC Single Dose sterile, and how should it be stored?
Futurabond DC Single Dose is non-sterile, so it should not be used in sterile field procedures. Storage should follow the manufacturer’s guidelines (VOCO GmbH) to maintain efficacy, though specific conditions like temperature or humidity are not detailed in the provided data.
What regulatory pathways has Futurabond DC Single Dose followed, and where is it manufactured?
The device has received FDA 510(k) clearance (traditional route, substantially equivalent to a predicate) and complies with the EU Medical Device Regulation (MDR). It is manufactured by VOCO GmbH at their facility in Cuxhaven, Germany (Anton-Flettner-Strasse 1-3, D-27472).
Are there multiple sizes or models of Futurabond DC Single Dose, or is it available in a single formulation?
The provided data does not specify multiple sizes or models for Futurabond DC Single Dose. It is described as a single-dose resin-based adhesive for tooth bonding, implying a standardized formulation for general dental restorative applications.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K070723 | Class II | Active |
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Manufacturer
- Manufacturer
- VOCO GmbH
Sources (2)
- FDA 510(k) K070723 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026