Identifiers
- 510(k) Number
- K062493 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)
LAVA SOFTWARE is a computer program used with the Lava system for CAD/CAM fabrication of dental restorations including inlays, onlays, veneers, crowns, and bridges. The software controls the measuring process and processing of data for creating dental prosthetics. It is designed to work specifically with 3M ESPE's all-ceramic dental system.
The software is supplied by 3M Espe AG Dental Products and has received FDA 510(k) clearance with K number K062493. It is classified under product code NHA as an Abutment, Implant, Dental, Endosseous device. The software is intended for use in dental laboratories and clinical settings for the digital design and manufacturing of dental restorations.
Frequently asked questions
What is the LAVA SOFTWARE used for?
LAVA SOFTWARE is a computer program designed to work with the Lava system for CAD/CAM fabrication of dental restorations including inlays, onlays, veneers, crowns, and bridges. It controls the measuring process and data processing for creating dental prosthetics.
How is the LAVA SOFTWARE supplied?
The software is supplied by 3M Espe AG Dental Products and is intended for use in dental laboratories and clinical settings for the digital design and manufacturing of dental restorations.
What regulatory approvals does LAVA SOFTWARE have?
LAVA SOFTWARE has received FDA 510(k) clearance with K number K062493. It is classified under product code NHA as an Abutment, Implant, Dental, Endosseous device.
What dental restorations can be created using LAVA SOFTWARE?
The software can be used to create various dental restorations including inlays, onlays, veneers, crowns, and bridges through its CAD/CAM fabrication process specifically designed for 3M ESPE's all-ceramic dental system.
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: LAVA SOFTWARE (K062493) — FDA 510(k) | Innolitics, K062493 FDA 510(k) - LAVA SOFTWARE | 3M Espe AG Dental Products, LAVA SOFTWARE by 3M ESPE AG DENTAL PRODUCTS | FDA 510(k) Summary
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K062493 | Class II | Active |
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Manufacturer
- Manufacturer
- 3M Espe AG Dental Products
Sources (1)
- FDA 510(k) K062493 24 fields · synced Oct 6, 2026