Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart B — Diagnostic Devices](/submissions/DE/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 872.1830](/submissions/DE/subpart-b%E2%80%94diagnostic-devices/872.1830) → EAG — Cephalometer

# EAG · Cephalometer

_Dental · 21 CFR 872.1830 · Class 2_

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

## Overview

- **Product Code:** EAG
- **Device Name:** Cephalometer
- **Regulation:** [21 CFR 872.1830](/submissions/DE/subpart-b%E2%80%94diagnostic-devices/872.1830)
- **Device Class:** 2
- **Review Panel:** [Dental](/submissions/DE)
- **3rd-party reviewable:** yes

## Identification

A cephalometer is a device used in dentistry during x-ray procedures. The device is intended to place and to hold a patient's head in a standard position during dental x-rays.

## Classification Rationale

Class II.

## Recent Cleared Devices (10 of 10)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K030699](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EAG/K030699.md) | VERAVIEWEPOCS PANORAMIC/CEPHALOMETRIC X-RAY UNIT WITH  CEPHALOMETRIC | J. Morita Mfg. Corp. | May 29, 2003 | SESE |
| [K021372](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EAG/K021372.md) | VERAVIEWEPOCS PANORAMIC X-RAY UNIT WITH CEPHALOMETRIC CAPABILITY | J. Morita USA, Inc. | Jun 7, 2002 | SESE |
| [K944162](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EAG/K944162.md) | DENAR ACCUCEPH CEPHALOMETER IMAGING SYSTEM | Teledyne Water Pik | Nov 29, 1994 | SESE |
| [K920189](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EAG/K920189.md) | GX-C CEPHALOMETER | Gendex Corp. | Apr 28, 1992 | SESE |
| [K896099](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EAG/K896099.md) | DIGIGRAPH DIAGNOSTIC WORK/STATION | Dolphin Imaging Systems | Jan 31, 1991 | SESE |
| [K870243](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EAG/K870243.md) | BURNETT TMJ APPLIANCE | Medrad, Inc. | Feb 24, 1987 | SESE |
| [K842463](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EAG/K842463.md) | GX CEPH | Gendex Corp. | Aug 2, 1984 | SESE |
| [K833006](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EAG/K833006.md) | CEPHALOMETER & FIXATOR | Modern Systems, Inc. | Jan 3, 1984 | SESE |
| [K810538](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EAG/K810538.md) | PLASTICEPH | Morningstar Dental Co. | Apr 29, 1981 | SESE |
| [K781287](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EAG/K781287.md) | DENTAL X-RAY UNIT W/CEPHALOMETRIC ATTACH | Siemens Corp. | Sep 11, 1978 | SESE |

## Top Applicants

- Gendex Corp. — 2 clearances
- Teledyne Water Pik — 1 clearance
- Siemens Corp. — 1 clearance
- Morningstar Dental Co. — 1 clearance
- Modern Systems, Inc. — 1 clearance

---

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

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com