Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart B — Diagnostic Devices](/submissions/DE/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 872.1770](/submissions/DE/subpart-b%E2%80%94diagnostic-devices/872.1770) → SBC — Dental Image Analyzer

# SBC · Dental Image Analyzer

_Dental · 21 CFR 872.1770 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/SBC

## Overview

- **Product Code:** SBC
- **Device Name:** Dental Image Analyzer
- **Regulation:** [21 CFR 872.1770](/submissions/DE/subpart-b%E2%80%94diagnostic-devices/872.1770)
- **Device Class:** 2
- **Review Panel:** [Dental](/submissions/DE)

## Identification

Dental Image Analyzer. A dental image analyzer is a prescription home use device that uses software intended to collect and analyze patient-specific, optical camera-based, intraoral images. The analyses are provided to dental health care professionals as an aid to diagnosis of oral health conditions and/or to monitor treatment progress.

## Classification Rationale

Class II (special controls). The device is classified as Class II because the probable benefits outweigh the probable risks, and the risks can be mitigated by the use of general and the identified special controls.

## Special Controls

In combination with the general controls of the FD&C Act. the Dental Image Analyzer is subject to the following special controls:

(1) The patient-contacting components of the device must be demonstrated to be biocompatible.

(2) Non-clinical performance testing data must demonstrate that the device performs as intended under anticipated conditions of use and must include full specifications of the hardware requirements and testing to demonstrate the specified hardware ensures adequate data for validated and accurate measurements; (3) Clinical performance data must demonstrate the accuracy and precision of the diagnostic and monitoring device algorithms to perform as intended under anticipated conditions of use.

(4) Usability testing must demonstrate that the user can correctly use the device, based solely on reading the directions for use.

(5) Software verification, validation, and hazard analysis must be performed.

(6) Labeling must include:

(i) Information on the patient population for which the device has been demonstrated to be effective.

(ii) Information on how the device operates during the typical course of treatment

(iii) A detailed summary of the device technical parameters, including compatible operating systems, hardware, and/or accessories.

(iv) Instructions for cleaning of any reusable components.

(v) Warning that the device is not intended to be used independently for diagnosis and that the device does not replace clinical decision making.

- (7) Patient labeling must be provided and must include:
(i) Relevant contraindications, warnings, precautions, adverse effects/complications, and when to seek help from a dental healthcare professional.

(ii) Information on how the device operates during the typical course of treatment.

(iii) A detailed summary of the device technical parameters, including compatible operating systems, hardware, and/or accessories.

(iv) Information on the patient population for which there is clinical evidence of effectiveness.

- (v) Instructions for cleaning of any reusable components.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [DEN230035](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/SBC/DEN230035.md) | DentalMonitoring | Dental Monitoring Sas | May 17, 2024 | DENG |

## Top Applicants

- Dental Monitoring Sas — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/SBC](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/SBC)

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