← Back to catalogue

Luminesse PMMA

FDA 510(k)

Class II (US FDA 510(k))

510(k) K142371

by Talladium, Inc.

Identifiers

510(k) Number
K142371 FDA 510(k)
FDA Product Code
EBG FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3770 FDA 510(k)
Regulation Number
872.3770 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Luminesse PMMA is a polymethylmethacrylate (PMMA) dental material classified as a Provisional Restorative Crown or Bridge (Product Code EBG). It is designed as a temporary restorative solution to protect prepared teeth during the fabrication of definitive crowns or bridges, ensuring structural integrity and aesthetic continuity while permanent restorations are created.

Supplied as 100mm shaded discs, the Luminesse PMMA is intended for use in dental laboratories and clinics for computer-aided design and manufacturing (CAD/CAM) workflows. It is a single-use material, requiring sterile handling and storage in a controlled environment to maintain performance. The device holds FDA 510(k) clearance (K142371) under the Traditional pathway, adhering to dental regulatory standards for provisional restorations.

Frequently asked questions

What is the Luminesse PMMA used for in dental procedures?

The Luminesse PMMA is designed as a provisional restorative material for temporary crowns or bridges. It protects prepared teeth during the fabrication of definitive restorations, maintaining structural integrity and aesthetic continuity while the permanent restoration is created. This is particularly useful in computer-aided design and manufacturing (CAD/CAM) workflows.

How is the Luminesse PMMA supplied, and what does it look like?

The Luminesse PMMA is supplied as 100mm diameter discs in various shades. These discs are intended for use in dental laboratories and clinics, providing a ready-to-use material for immediate placement in provisional restorations. The discs are pre-shaded to match natural tooth tones.

Is the Luminesse PMMA sterile, and how should it be stored?

Yes, the Luminesse PMMA requires sterile handling due to its single-use nature. It must be stored in a controlled environment to preserve its performance and sterility. Proper storage conditions ensure the material remains uncontaminated and ready for use in clinical settings.

Can the Luminesse PMMA be reused, or is it intended for single-use only?

The Luminesse PMMA is explicitly designed for single-use only. Reusing the material could compromise its structural integrity, sterility, and clinical performance. Single-use ensures patient safety and consistency in outcomes during the provisional restoration phase.

What regulatory pathway does the Luminesse PMMA follow, and what does that mean for clinicians?

The Luminesse PMMA holds FDA 510(k) clearance under the Traditional pathway, classified as a Provisional Restorative Crown or Bridge (Product Code EBG). This means it has been evaluated and determined to be substantially equivalent to a legally marketed device, ensuring it meets established dental safety and performance standards for provisional restorations.

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: K142371 FDA 510 (k) - Luminesse PMMA | Talladium, Inc., Luminesse PMMA (K142371) — FDA 510(k) | Innolitics, Luminesse Shaded Pmma Discs For Cad/cam 100mm (Talladium) | Dental ..., Luminesse Shaded PMMA Discs, 100mm (Talladium) | Dental Product ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Talladium, Inc.

Sources (1)

  • FDA 510(k) K142371 24 fields · synced Oct 1, 2026