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Mirage Bond

FDA 510(k)

Class II (US FDA 510(k))

510(k) K884137

by Chameleon Dental Products, Inc.

Identifiers

510(k) Number
K884137 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)

Mirage Bond is a resin-based dental adhesive classified as an Agent, Tooth Bonding. It is designed to bond restorative materials directly to tooth structure, ensuring a durable and chemically stable attachment between the restoration and the natural tooth.

Mirage Bond is supplied as a single-use dental adhesive for professional use in clinical settings. It is classified under FDA regulation 872.3200 and has received FDA 510(k) clearance (K884137) as substantially equivalent. The product is non-sterile and intended for use by trained dental professionals. No MRI safety information is provided.

Mirage Bond

Frequently asked questions

What is Mirage Bond used for?

Mirage Bond is a resin-based dental adhesive designed to bond restorative materials directly to tooth structure. It ensures a durable and chemically stable attachment between dental restorations and natural teeth, helping to maintain long-term integrity of the repair.

Is Mirage Bond single-use or reusable?

Mirage Bond is supplied as a single-use dental adhesive. This classification ensures sterility and safety for each clinical procedure, reducing the risk of cross-contamination between patients.

What is the sterility status of Mirage Bond?

Mirage Bond is non-sterile. It is intended for professional use in clinical settings and must be handled in accordance with standard dental infection control protocols to ensure safe application.

How is Mirage Bond supplied?

Mirage Bond is supplied as a single-use adhesive, packaged for professional dental use. The packaging ensures the product remains uncontaminated until use, adhering to dental practice standards for hygiene and safety.

Does Mirage Bond require any special storage conditions?

While specific storage instructions are not detailed in the provided data, dental adhesives like Mirage Bond are generally recommended to be stored in a cool, dry place, away from direct sunlight and extreme temperatures. Always follow the manufacturer’s guidelines to maintain product efficacy.

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. Sources consulted: MIRAGE BOND (K884137) — FDA 510(k) | Innolitics, CHAMELEON DENTAL PRODUCTS, INC - RevMed, MIRAGE BOND 510 (k) K884137 - FDA.report, CHAMELEON DENTAL PRODUCTS, INC PBEK Mirage Prolong Bond ... - RevMed

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Chameleon Dental Products, Inc.

Sources (1)

  • FDA 510(k) K884137 24 fields · synced Oct 1, 2026