Product code EAG— Dental

FDA has cleared 10 devices under product code EAG between 1978 and 2003, filed by 9 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20031 clearance
• 20021 clearance
• 19941 clearance
• 19921 clearance
• 19911 clearance
• 19871 clearance
• 19842 clearances
• 19811 clearance
• 19781 clearance

• Gendex Corp.2 clearances
• Teledyne Water Pik1 clearance
• Siemens Corp.1 clearance
• Morningstar Dental Co.1 clearance
• Modern Systems, Inc.1 clearance
• Medrad, Inc.1 clearance
• J. Morita USA, Inc.1 clearance
• J. Morita Mfg. Corp.1 clearance
• Dolphin Imaging Systems1 clearance

• K030699 — VERAVIEWEPOCS PANORAMIC/CEPHALOMETRIC X-RAY UNIT WITH CEPHALOMETRICJ. Morita Mfg. Corp.·2003-05-29
• K021372 — VERAVIEWEPOCS PANORAMIC X-RAY UNIT WITH CEPHALOMETRIC CAPABILITYJ. Morita USA, Inc.·2002-06-07
• K944162 — DENAR ACCUCEPH CEPHALOMETER IMAGING SYSTEMTeledyne Water Pik·1994-11-29
• K920189 — GX-C CEPHALOMETERGendex Corp.·1992-04-28
• K896099 — DIGIGRAPH DIAGNOSTIC WORK/STATIONDolphin Imaging Systems·1991-01-31
• K870243 — BURNETT TMJ APPLIANCEMedrad, Inc.·1987-02-24
• K842463 — GX CEPHGendex Corp.·1984-08-02
• K833006 — CEPHALOMETER & FIXATORModern Systems, Inc.·1984-01-03
• K810538 — PLASTICEPHMorningstar Dental Co.·1981-04-29
• K781287 — DENTAL X-RAY UNIT W/CEPHALOMETRIC ATTACHSiemens Corp.·1978-09-11