Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart D — Prosthetic Devices](/submissions/DE/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 872.3730](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3730) → KCS — Pantograph

# KCS · Pantograph

_Dental · 21 CFR 872.3730 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KCS

## Overview

- **Product Code:** KCS
- **Device Name:** Pantograph
- **Regulation:** [21 CFR 872.3730](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3730)
- **Device Class:** 1
- **Review Panel:** [Dental](/submissions/DE)
- **GMP exempt:** yes

## Identification

A pantograph is a device intended to be attached to a patient's head to duplicate lower jaw movements to aid in construction of restorative and prosthetic dental devices. A marking pen is attached to the lower jaw component of the device and, as the patient's mouth opens, the pen records on graph paper the angle between the upper and the lower jaw.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KCS](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KCS)

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