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Ribbond

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K913040

by Ribbond, Inc.

Identifiers

510(k) Number
K913040 FDA 510(k)
FDA Product Code
EBI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3760 FDA 510(k)
Regulation Number
872.3760 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Ribbond is a dental adhesive used for bonding orthodontic brackets to teeth. Classified as a dental bonding agent, it provides a durable mechanical attachment for orthodontic appliances, ensuring stability during treatment.

This device is supplied as a liquid adhesive, intended for single-use applications in clinical dental settings. It is not sterile as packaged but must be used under aseptic conditions. The product is regulated under FDA 510(k) clearance (K913040) and conforms to the Medical Device Directive (MDD). No MRI safety information is specified.

Frequently asked questions

What is RIBBOND™ used for in clinical settings?

RIBBOND™ is a dental adhesive specifically designed to bond orthodontic brackets securely to teeth. It creates a strong mechanical attachment, ensuring the brackets remain stable throughout orthodontic treatment. This helps maintain proper alignment and treatment progression.

Is RIBBOND™ intended for reuse or single-use in a dental office?

RIBBOND™ is supplied as a liquid adhesive for single-use applications only. Since it is not sterile as packaged, it must be used under aseptic conditions in clinical settings, meaning each application requires a fresh dose from the container.

How should RIBBOND™ be stored, and are there any special handling requirements?

While the exact storage conditions aren’t detailed, RIBBOND™ is a liquid adhesive intended for clinical use under aseptic conditions. It should be stored according to the manufacturer’s instructions (likely at room temperature, protected from contamination) to maintain its effectiveness. Since it’s not sterile as packaged, proper hygiene protocols must be followed when handling.

What regulatory pathways does RIBBOND™ follow, and how is its equivalence classified?

RIBBOND™ is regulated under the FDA 510(k) clearance process (with clearance number K913040) and also conforms to the Medical Device Directive (MDD). The FDA classified it as substantially equivalent to a predicate device, meaning its safety and performance were determined to be comparable to an existing orthodontic adhesive.

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

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ribbond, Inc.

Sources (2)

  • FDA 510(k) K913040 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 29, 2026