Identifiers
- 510(k) Number
- K182350 FDA 510(k)
- FDA Product Code
- EIH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.6660 FDA 510(k)
- Regulation Number
- 872.6660 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Dental Ceramic is classified as a dental restorative material, specifically a ceramic used for dental prosthetics and restorations. It is designed to provide durable, aesthetically pleasing dental repairs, including crowns, bridges, inlays, and onlays, by mimicking the natural appearance and strength of tooth enamel.
This device is supplied as a pre-fabricated ceramic block intended for milling or grinding by dental technicians or clinicians to create custom restorations. It is classified under the Product Code EIH and is intended for single-use applications in dental settings. The device holds FDA 510(k) clearance under the Traditional pathway, with a determination of Substantially Equivalent, and complies with the Medical Device Directive (MDD) and Medical Device Regulation (MDR) standards.
Frequently asked questions
What types of dental restorations can this Dental Ceramic material be used to create, and how is it prepared for use?
This Dental Ceramic is specifically designed for creating durable, natural-looking dental restorations such as crowns, bridges, inlays, and onlays. It comes as a pre-fabricated ceramic block that must be milled or ground by dental technicians or clinicians to custom-fit a patient’s teeth. The material mimics the appearance and strength of tooth enamel, ensuring both functionality and aesthetics in the final restoration.
Is this Dental Ceramic intended for reuse, or is it meant to be used only once per patient?
The Dental Ceramic is explicitly classified for single-use applications in dental settings. Once milled or shaped for a specific restoration, it should not be reused for another patient. This ensures patient safety and maintains the integrity of the restoration process.
What regulatory pathways has this Dental Ceramic followed, and what does that mean for its use in dental practices?
This Dental Ceramic holds FDA 510(k) clearance under the Traditional pathway, determined to be *Substantially Equivalent* to a predicate device, and complies with the Medical Device Directive (MDD) and Medical Device Regulation (MDR) standards. This means it has undergone evaluation to meet safety and performance requirements for dental restorative materials, allowing it to be legally used in clinical settings where such devices are permitted.
How is this product supplied, and what should clinicians consider when handling or storing it?
The Dental Ceramic is supplied as a pre-fabricated ceramic block intended for milling or grinding by dental professionals. Since it is single-use, clinicians should handle it with care to avoid contamination before use. Storage should follow standard dental material protocols—typically in a clean, dry environment, protected from moisture or physical damage, until ready for processing.
What does the Product Code *EIH* indicate about how this device is categorized and regulated?
The Product Code EIH classifies this Dental Ceramic under dental restorative materials, specifically for prosthetics and restorations like crowns and bridges. This classification helps regulators and clinicians identify its intended use within the broader dental device landscape, ensuring it adheres to applicable safety and performance standards for its category.
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
MDR
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K182350 | Class II | Active |
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Manufacturer
- Manufacturer
- BAOT Biological Technology Co., Ltd.
Sources (2)
- FDA 510(k) K182350 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 11, 2026