Jumbo Silver-Reinforced Glass Ionomer
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K982665 FDA 510(k)
- FDA Product Code
- EMA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3275 FDA 510(k)
- Regulation Number
- 872.3275 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a Dental Cement (FDA classification: Class II), specifically a glass ionomer cement reinforced with silver particles. It is designed to restore tooth defects or cavities by providing structural integrity and adhesion to tooth surfaces, ensuring durable and biocompatible dental repairs.
The Jumbo Silver-Reinforced Glass Ionomer is supplied as a dental restorative material for use in clinical settings by dental professionals. It is intended for single-use applications and is not sterilized post-manufacture. The device is regulated under FDA 510(k) clearance (K982665) and falls under the regulatory category 872.3275. Multiple lot/registration numbers are associated with its distribution, but no MRI safety or reusable specifications are noted.
Frequently asked questions
What is the primary purpose of the Jumbo Silver-Reinforced Glass Ionomer in dental procedures?
The Jumbo Silver-Reinforced Glass Ionomer is specifically designed to restore tooth defects or cavities by providing durable structural integrity and strong adhesion to tooth surfaces. The silver reinforcement enhances its mechanical properties, making it suitable for long-lasting dental repairs while maintaining biocompatibility.
Is this product intended for reuse, or is it meant for single-use applications?
This product is explicitly intended for single-use applications only. It is not sterilized post-manufacture, which aligns with its classification as a single-use dental material.
How is the Jumbo Silver-Reinforced Glass Ionomer regulated by the FDA, and what does that mean for its use?
The device is regulated under the FDA’s 510(k) clearance process (K982665) and falls under the classification of Class II dental cement. This means it has been determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets FDA safety and effectiveness standards for dental restorative use.
What should clinicians consider regarding storage or handling of this product?
Since the product is not sterilized post-manufacture and is intended for single-use, clinicians should handle it in a sterile field during use. Storage conditions are not explicitly detailed, but typical dental materials of this type are generally stored in a cool, dry place away from direct sunlight until use.
Does this product have any special considerations for patients, such as MRI safety?
The provided data does not mention any MRI safety specifications for the Jumbo Silver-Reinforced Glass Ionomer. Clinicians should confirm with the manufacturer if MRI compatibility is a concern for their specific patient cases.
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: Jumbo Silver-reinforced Glass Ionomer 510 (k) FDA Premarket ..., JUMBO SILVER-REINFORCED GLASS IONOMER - Innolitics, Jumbo Silver-reinforced Glass Ionomer - Beudamed, PDF K982665 - Jumbo Silver-reinforced Glass Ionomer, JUMBO SILVER-REINFORCED GLASS IONOMER - Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K982665 | Class II | Active |
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Manufacturer
- Manufacturer
- Centrix, Inc.
Sources (1)
- FDA 510(k) K982665 24 fields · synced Sep 19, 2026