Identifiers
- 510(k) Number
- K910263 FDA 510(k)
- FDA Product Code
- EBF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3690 FDA 510(k)
- Regulation Number
- 872.3690 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Charisma is a dental composite resin filling material designed for posterior and anterior restorations. It is classified as a dental restorative material, offering ceramic reinforcement for enhanced mechanical properties and aesthetic results in direct restorative applications.
Supplied as a two-component system, Charisma is intended for single-use per application and requires mixing before use. The product is packaged in universal shade shades and is regulated under FDA 510(k) clearance (K910263) as a substantially equivalent dental device. Storage conditions and regulatory compliance are governed by the manufacturer’s specifications, ensuring suitability for clinical use in dental offices.
Frequently asked questions
What types of dental restorations is Charisma designed for, and why is it considered suitable for both front and back teeth?
Charisma is specifically formulated as a dental composite resin filling material for both posterior (back) and anterior (front) restorations. Its ceramic reinforcement enhances mechanical strength, making it durable for chewing surfaces while also providing aesthetic results suitable for visible front teeth. This dual-purpose design ensures versatility for general dental restorative needs.
How is Charisma supplied, and what does the two-component system mean for its use in a dental office?
Charisma comes as a two-component system, meaning it requires mixing before application. This design ensures optimal performance by combining the resin and ceramic filler components precisely for each restoration. Since it’s intended for single-use per application, each package is meant to be used once, reducing contamination risks and ensuring consistency in treatment outcomes.
Are there specific shade options available for Charisma, and how might this affect its clinical application?
Charisma is supplied in universal shade options, which allows dentists to match the natural color of a patient’s teeth for both anterior and posterior restorations. This versatility in shade selection ensures better aesthetic integration, making it suitable for a wide range of dental restoration needs without requiring custom ordering.
Is Charisma intended for reuse, or is it designed for single-use applications? How does this impact storage and handling?
Charisma is explicitly designed for single-use per application, meaning each package should only be used once. This design minimizes the risk of cross-contamination and ensures the material remains sterile and effective for the intended restoration. Clinicians should store unopened packages according to the manufacturer’s guidelines to maintain sterility until use.
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: Charisma - Kulzer.com, Charisma - Kulzer, Charisma - Brands - shop.kulzer.com, PDF Charisma Naturally reliable. - Kulzerus.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K910263 | Class II | Active |
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Manufacturer
- Manufacturer
- Kulzer, Inc.
Sources (1)
- FDA 510(k) K910263 24 fields · synced Sep 19, 2026