Calcivis Imaging System
by Calcivis Limited PMA
Active
PMA P170029
Overview
The Calcivis Imaging System is a Caries Detection Product with Drug or Biologic, classified as a Class III device under FDA regulations. It is designed to generate images of active demineralization on coronal tooth surfaces, aiding in the assessment, diagnosis, and treatment planning of caries-related demineralization in patients aged six years and older.
This system is intended for use by dental healthcare professionals in clinical settings. It is supplied as a reusable device with FDA PMA approval (P170029) and is not indicated for MRI use. The system operates on accessible tooth surfaces and requires no specific sterility measures beyond standard dental practice protocols. Storage and handling follow manufacturer guidelines to maintain functionality.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP170029 | Date7 Mar 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA PMA Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- Generic Name
- Caries detection product with drug or biologic
- PMA Number
- FDA Product Code
- QJX
- Device Class
- Class III
- Advisory Committee
- Dental
- FDA Decision
- APPR Approved
Questions
What is the primary purpose of the Calcivis Imaging System in dental care and who can use it?
The Calcivis Imaging System is designed to generate images of active demineralization on coronal tooth surfaces, helping dental professionals assess, diagnose, and plan treatment for caries-related issues in patients aged six and older. It is intended exclusively for use by dental healthcare professionals in clinical settings.
Is the Calcivis Imaging System single-use or reusable, and what sterility considerations apply?
The Calcivis Imaging System is a reusable device. Since it operates on accessible tooth surfaces in clinical settings, standard dental practice protocols for sterility and infection control—rather than specialized sterility measures—apply during use.
What age group is the Calcivis Imaging System approved for, and what specific tooth surfaces does it target?
The system is approved for use on patients aged six years and older. It is specifically intended for imaging active demineralization on accessible coronal tooth surfaces, which are the front-facing surfaces of teeth.
How is the Calcivis Imaging System regulated in the U.S., and what does its classification mean?
The Calcivis Imaging System is classified as a Class III medical device under FDA regulations and holds a Premarket Approval (PMA) designation (P170029). This classification means it undergoes rigorous review to ensure safety and effectiveness, as it involves significant risk and is intended to diagnose or treat conditions like caries-related demineralization.
Can the Calcivis Imaging System be used in conjunction with MRI, or are there any special handling instructions?
The system is explicitly **not** indicated for use in MRI environments. While no specialized sterility measures are required beyond standard dental protocols, the manufacturer’s guidelines for storage and handling must be followed to maintain proper functionality and performance.