FDA 510(k) Applications for Medical Device Product Code "EAX"
(Mirror, Mouth)

FDA 510(k) Number Applicant Device Name Decision Date
K830777 ALMORE INTL., INC. ELECTRIC MOUTH MIRROR 04/06/1983
K935687 DENTALSAFE SYSTEMS PTY., LTD. NIL 02/03/1994
K833429 DENTEC, INC. PERI MIRROR/SALIVA EJECTOR 12/22/1983
K841199 HENRY SCHEIN, INC. FIBERGLASS MOUTH MIRRORS 04/25/1984
K946073 HINES GROUP LTD. ORALVUE DENTAL MIRROR 02/16/1995
K833310 HTI, INC. FOGCUTTER DENTAL MOUTH MIRROR 05/07/1984
K821777 PACIFIC DENTAL CORP. BEACH MOUTH MIRROR 07/06/1982
K935906 RANIR/DCP CORP. RANIR PLAX RX 09/02/1994
K800919 TELEDYNE, INC. ORAVIEW BY WATER PIK 05/08/1980
K863766 THE MEDICAL GROUP, INC. DISPOSABLE MOUTH MIRRORS, SINGLE USE ONLY 10/30/1986
K863767 THE MEDICAL GROUP, INC. GLASS MOUTH MIRRORS, REUSABLE 10/30/1986
K941574 UNION BROACH, DIV. MOYCO INDUSTRIES, INC. RETRO MIRROR 05/18/1994


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