Premium Shelta Prosthetic Components
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K162028 FDA 510(k)
- FDA Product Code
- NHA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3630 FDA 510(k)
- Regulation Number
- 872.3630 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Premium Shelta Prosthetic Components are classified as dental prosthetic devices designed to restore form and function to missing teeth or oral structures. These components are engineered to provide durable, customizable solutions for partial or full denture frameworks, ensuring compatibility with various dental restorations and prosthodontic treatments.
Supplied as reusable components, these devices are intended for use in dental clinics and laboratories under sterile conditions. They are manufactured to meet FDA 510(k) clearance and MDD compliance standards, with a product code of NHA. Storage and handling must adhere to dental practice protocols to maintain integrity and sterility prior to clinical application.
Frequently asked questions
Are these prosthetic components designed for single-use or can they be reused in multiple patients?
The Premium Shelta Prosthetic Components are explicitly labeled as reusable, meaning they are intended for use across multiple patients in dental clinics or laboratories. Their design and manufacturing comply with sterile handling protocols, ensuring they can be properly cleaned, disinfected, and reused while maintaining safety and functionality. Clinics must follow standard dental practice protocols for sterilization and storage to preserve their integrity before each use.
What types of dental restorations or prosthodontic treatments are these components compatible with?
These components are engineered to support partial or full denture frameworks, providing a durable and customizable solution for restoring missing teeth or oral structures. Their design ensures compatibility with a variety of dental restorations and prosthodontic treatments, though specific applications depend on the clinician’s assessment and the patient’s unique needs. They are not limited to a single treatment type but are versatile for general prosthodontic use.
How should these prosthetic components be stored to maintain their sterility and integrity before use?
The Premium Shelta Prosthetic Components must be stored and handled according to dental practice protocols to preserve sterility and structural integrity. Since they are reusable, they should be kept in a clean, dry environment—preferably in sealed packaging or sterile containers—until ready for use. Proper cleaning, disinfection, and sterilization procedures must be followed before each clinical application to ensure safety and compliance with regulatory standards.
What regulatory pathways have these components undergone, and how does that affect their use?
The Premium Shelta Prosthetic Components have undergone FDA 510(k) clearance and comply with the MDD (Medical Device Directive) standards in Europe. Their classification as substantially equivalent (SESE) under the FDA’s traditional review process confirms they meet established safety and performance criteria for dental prosthetic devices. Clinicians can rely on these approvals to ensure the components adhere to regulatory requirements for use in dental clinics and laboratories, though local regulations should always be consulted for specific implementation.
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
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K162028 | Class II | Active |
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Manufacturer
- Manufacturer
- Sweden & Martina S.p.a.
Sources (2)
- FDA 510(k) K162028 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026