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Diagnostic devices · 21 CFR 872 Subpart B

Cephalometer

FDA device type “Cephalometer”.

FDA codeEAGClass221 CFR872.1830Pathway510(k)
Companies listing it
11 makers
Brands and models
1
510(k) clearances
100 in five years
FDA name
Cephalometer
1978: 11981: 11984: 21987: 11991: 11992: 11994: 12002: 12003: 119801990200020102020

510(k) clearances per year, 1976–2026

Companies that list EAG

1 company currently list this device type with FDA.

CompanyCountryRoleBrands and models listedClearancesLatest
Bayer Medical Care Inc.United StatesMakerBurnett TMJ Appliance——

510(k) clearances

Decided510(k)DeviceApplicant
29 May 2003K030699VERAVIEWEPOCS PANORAMIC/CEPHALOMETRIC X-RAY UNIT WITH CEPHALOMETRICJ. Morita Mfg. Corp.
7 Jun 2002K021372VERAVIEWEPOCS PANORAMIC X-RAY UNIT WITH CEPHALOMETRIC CAPABILITYJ. Morita USA, Inc.
29 Nov 1994K944162DENAR ACCUCEPH CEPHALOMETER IMAGING SYSTEMTeledyne Water Pik
28 Apr 1992K920189GX-C CEPHALOMETERGendex Corp.
31 Jan 1991K896099DIGIGRAPH DIAGNOSTIC WORK/STATIONDolphin Imaging Systems
24 Feb 1987K870243BURNETT TMJ APPLIANCEMedrad, Inc.
2 Aug 1984K842463GX CEPHGendex Corp.
3 Jan 1984K833006CEPHALOMETER & FIXATORModern Systems, Inc.
29 Apr 1981K810538PLASTICEPHMorningstar Dental Co.
11 Sep 1978K781287DENTAL X-RAY UNIT W/CEPHALOMETRIC ATTACHSiemens AG

Official records: FDA product classification for EAG · 21 CFR 872.1830.

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026