FDA 510(k) Applications for Medical Device Product Code "EAZ"
(Light, Operating, Dental)

FDA 510(k) Number Applicant Device Name Decision Date
K893044 A-DEC, INC. A-DEC DENTAL LIGHT 07/14/1989
K041614 ADDENT, INC. MICROLUX DL 04/04/2005
K072309 ADDENT, INC. MICROLUX/BLU 11/19/2007
K772351 CHEMETRON DENTAL PRODUCTS DENTAL LIGHT 01/17/1978
K912997 DABI-ATLANTE AMERICA CORP. MINIFLEX AND PERSONAL UNIT 10/30/1991
K902685 DEFIANCE ELECTRONICS, INC. DEFIANCE MODEL FUS 336 09/17/1990
K925629 DEN-TAL-EZ MFG CO., INC. ACCESSORY TO IMPROVED DENTAL OPERATING LIGHT 11/23/1993
K832919 DENTSPLY INTL. OPTI-BEAM IV 03/02/1984
K894059 EURODENT, INC. ISOLIGHT 09/07/1989
K790984 INNOVATORS, INC. KLIP-LITE 10/22/1979
K771249 M.D. INTL., INC. JOY LIGHT 07/15/1977
K926081 MDT CORP., INC. DENTAL LIGHT 01/26/1994
K912142 MICRONAIRE CORP. MICRONAIRE ISO-HOOD MAX 5UV 10/30/1991
K801683 PACIFIC DENTAL CORP. LUNA-VUE DENTAL OPERATING LIGHT 08/04/1980
K935390 PELTON & CRANE CO. SIROLUX FANTASTIC 12/10/1993
K923462 PLANMECA USA, INC. DELIGHT 12/21/1992
K891216 PRO-SAFE PROFESSIONAL LINENS, INC. DENTAL EQUIPMENT PROTECTION DEVICES 06/02/1989
K760707 RITTER CO. RITTER STARLIGHT DENTAL OPERATING LIGHT 10/05/1976
K863019 SDS DENTAL, INC. F-11 REFLECTOR / F-II STANDARD REFLECTOR 09/29/1986
K884223 STERI-SHIELD PRODUCTS, INC. DENTAL LAMP HANDLE COVER 03/17/1989
K003995 TRYLON CORP. SPECULITE/ORALLITE 03/16/2001
K033033 TRYLON CORP. VIZILITE-BLUE ORAL EXAM KIT 11/22/2004
K874374 WOOG INTL. THE WOOG ORATEST 01/19/1988


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact