EAG · Cephalometer
Dental · 21 CFR 872.1830 · Class 2
Overview
| Product Code | EAG |
|---|---|
| Device Name | Cephalometer |
| Regulation | 21 CFR 872.1830 |
| Device Class | Class 2 |
| Review Panel | Dental |
| 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 | VERAVIEWEPOCS PANORAMIC/CEPHALOMETRIC X-RAY UNIT WITH CEPHALOMETRIC | J. Morita Mfg. Corp. | May 29, 2003 | SESE |
| K021372 | VERAVIEWEPOCS PANORAMIC X-RAY UNIT WITH CEPHALOMETRIC CAPABILITY | J. Morita USA, Inc. | Jun 7, 2002 | SESE |
| K944162 | DENAR ACCUCEPH CEPHALOMETER IMAGING SYSTEM | Teledyne Water Pik | Nov 29, 1994 | SESE |
| K920189 | GX-C CEPHALOMETER | Gendex Corp. | Apr 28, 1992 | SESE |
| K896099 | DIGIGRAPH DIAGNOSTIC WORK/STATION | Dolphin Imaging Systems | Jan 31, 1991 | SESE |
| K870243 | BURNETT TMJ APPLIANCE | Medrad, Inc. | Feb 24, 1987 | SESE |
| K842463 | GX CEPH | Gendex Corp. | Aug 2, 1984 | SESE |
| K833006 | CEPHALOMETER & FIXATOR | Modern Systems, Inc. | Jan 3, 1984 | SESE |
| K810538 | PLASTICEPH | Morningstar Dental Co. | Apr 29, 1981 | SESE |
| K781287 | 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
