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K-Bond Universal

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K241445

by Spident Co., Ltd.

Identifiers

510(k) Number
K241445 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)

The K-Bond Universal is a Tooth Bonding Agent, Resin, classified as a Class II dental device under FDA regulation 872.3200. It is designed for bonding dental restorations, including composites, ceramics, and metals, to tooth structure using a resin-based adhesive system. This adhesive facilitates durable mechanical retention in restorative procedures, ensuring long-term stability of dental restorations.

Supplied as a single-use, non-sterile kit, the K-Bond Universal is intended for use in dental clinics and offices. It requires no special storage conditions beyond protection from extreme temperatures and moisture. The device has received FDA 510K clearance and MDR authorization, confirming compliance with regulatory standards for dental adhesives. No MRI safety information is specified, and the product is not intended for reusable applications.

Frequently asked questions

What types of dental restorations can the K-Bond Universal be used to bond, and how does it ensure long-term stability?

The K-Bond Universal is designed for bonding dental restorations such as composites, ceramics, and metals to tooth structure. It achieves long-term stability through a resin-based adhesive system that provides durable mechanical retention, ensuring the restoration remains securely attached over time.

Is the K-Bond Universal kit single-use or reusable, and what storage conditions are required?

The K-Bond Universal is supplied as a single-use kit, meaning each package is intended for one procedure only. No special storage conditions are required beyond protecting it from extreme temperatures and moisture, making it convenient for use in dental clinics and offices.

Does the K-Bond Universal require any special handling or preparation before use, and is it sterile?

The K-Bond Universal is non-sterile and supplied as a ready-to-use kit, so no additional sterilization or special handling is required before application. However, standard dental aseptic techniques should still be followed to maintain a clean workspace.

What regulatory approvals does the K-Bond Universal have, and how does this affect its use in clinical settings?

The K-Bond Universal has received FDA 510(k) clearance and MDR authorization, confirming compliance with regulatory standards for dental adhesives. This means it meets the necessary safety and performance requirements for use in dental clinics and offices, ensuring its suitability for bonding restorations as described.

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

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Spident Co., Ltd.

Sources (2)

  • FDA 510(k) K241445 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced Jun 18, 2026