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Procera Software, Model 33145

FDA 510(k)

Class II (US FDA 510(k))

510(k) K053602

by Nobel Biocare AB

Identifiers

510(k) Number
K053602 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)

Procera Software, Model 33145 is a dental software application designed to import patient-specific data from scanners. It is used to define the shapes of dental prosthetic devices, including dental abutments and copings.

This software is provided by Nobel Biocare AB and is subject to FDA 510(k) authorization. It is intended for installation and configuration on compatible computer systems to facilitate the design of dental restorations.

Frequently asked questions

What is the primary function of Procera Software, Model 33145?

This software application is designed to import patient-specific data from dental scanners. It allows clinicians and technicians to define the precise shapes of dental prosthetic devices, specifically dental abutments and copings.

How is this software implemented in a clinical or laboratory setting?

The software is intended for installation and configuration on compatible computer systems. Once installed, it serves as a digital tool to facilitate the design process of dental restorations using imported scan data.

What is the regulatory status of this dental software?

Procera Software, Model 33145, is subject to FDA 510(k) authorization. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.

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: Digital libraries | Nobel Biocare, Paths to Procera™ | Nobel Biocare United States, Procera Software Installation Guide | Manualzz, PROCERA SOFTWARE, MODEL 33145 (K053602) — FDA 510(k) | Innolitics, PDF K053602 - Procera Software, Model 33145

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Nobel Biocare AB

Sources (1)

  • FDA 510(k) K053602 24 fields · synced Oct 6, 2026