Identifiers
- 510(k) Number
- K100232 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 device is a dental blank used in the fabrication of dental restorations. It is substantially equivalent to a legally marketed predicate device as determined by FDA 510(k) clearance.
It is supplied by Talladium, Inc. and is intended for use in dental laboratories. The device is non-sterile and reusable, with no MRI safety information provided in the data. Storage and handling should follow manufacturer guidelines.
Frequently asked questions
What is the LUMINESSE ZR BLANKS device used for?
The LUMINESSE ZR BLANKS device is a dental blank used in the fabrication of dental restorations, intended for use in dental laboratories to create prosthetic dental components.
How is the LUMINESSE ZR BLANKS device supplied and is it sterile or reusable?
The device is supplied by Talladium, Inc. as non-sterile and reusable, meaning it can be cleaned and used multiple times in accordance with manufacturer guidelines for handling and storage.
What regulatory pathway was used for the LUMINESSE ZR BLANKS device?
The device received FDA 510(k) clearance, demonstrating substantial equivalence to a legally marketed predicate device, as indicated by its authorization type and decision description.
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 (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K100232 | Class II | Active |
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Manufacturer
- Manufacturer
- Talladium, Inc.
Sources (1)
- FDA 510(k) K100232 24 fields · synced Sep 21, 2026