Identity
- Trade Name
- LOGICON CARIES DETECTOR FDA PMA
- Generic Name
- Analyzer, medical image FDA PMA
Identifiers
- PMA Number
- P980025 FDA PMA
- FDA Product Code
- MYN FDA PMA
Classification
- Device Class
- Class II FDA PMA
- Legislation / Framework
- 21 CFR Part 892.2070 FDA PMA
- Regulation Number
- 892.2070 FDA PMA
- Advisory Committee
- Radiology FDA PMA
- FDA Decision
- APRL FDA PMA
The Logicon Caries Detector is a software decision aid classified as an Analyzer, Medical Image. It assists in diagnosing caries that have penetrated into the dentin on unrestored proximal surfaces of secondary dentition by analyzing digital intra-oral radiographic imagery.
This device operates as an adjunct to the Trextrophy RVG digital x-ray radiographic system with TWI Software Version 3.0 or higher. It is supplied as a software solution and is not intended for standalone use. The device received FDA Premarket Approval under PMA number P980025 and is regulated under 21 CFR 892.2070.
Frequently asked questions
What specific dental condition does the Logicon Caries Detector help diagnose, and how does it work?
The Logicon Caries Detector assists in diagnosing caries (tooth decay) that have progressed into the dentin layer on the inner surfaces of permanent teeth (secondary dentition) that are not yet filled. It analyzes digital intra-oral X-ray images captured by the Trextrophy RVG system (with TWI Software Version 3.0 or higher) to provide an adjunctive decision aid for identifying these early-stage cavities.
Is the Logicon Caries Detector a standalone software tool, or does it require integration with another system?
The Logicon Caries Detector is not designed for standalone use. It operates exclusively as an adjunct to the Trextrophy RVG digital X-ray radiographic system, specifically requiring TWI Software Version 3.0 or higher for functionality.
What regulatory pathway was followed for the approval of this device, and under which FDA classification does it fall?
The Logicon Caries Detector received FDA Premarket Approval (PMA) under PMA number P980025, indicating it is classified as a Class II medical device under 21 CFR 892.2070. This classification applies to Analyzers, Medical Image, specifically for dental caries detection.
Are there multiple versions or models of the Logicon Caries Detector, and how are they differentiated?
The device is supplied as a single software solution and does not have distinct physical models. However, it is associated with multiple registration numbers (e.g., 3017840913, 3024891354, etc.) in the FDA database, which may reflect variations in licensing or distribution but do not imply separate hardware or software iterations.
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_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P980025 | Class II | Active |
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Manufacturer
- Manufacturer
- Carestream Dental LLC
- FDA Applicant
- Carestream Dental, LLC
Sources (1)
- FDA PMA P980025 24 fields · synced Sep 18, 2026