FDA 510(k) Applications for Medical Device Product Code "DZA"
(Drill, Dental, Intraoral)

FDA 510(k) Number Applicant Device Name Decision Date
K801887 AESCULAP INSTRUMENTS CORP. DRILL, DENTAL 08/20/1980
K801888 AESCULAP INSTRUMENTS CORP. HANDPIECE, DENTAL 08/20/1980
K811113 ALLOMEDIC RIESS-LUHR 06/16/1981
K760956 AMERICAN SAFETY EQUIPMENT CORP. SURGICAL MICRO DRILL 11/19/1976
K962979 DEL MEDICAL SYSTEMS CORP. S-53 INTRORAL DENTAL SYSTEM 09/25/1996
K761275 DENTSPLY INTL. AIROTOS "LF" HANDPIECE 12/23/1976
K914724 IMPLANT CORP. OF AMERICA ADA SHANK EXTENSION 07/27/1993
K901097 IVOCLAR NORTH AMERICA, INC. FILLOCK REAMER 04/25/1990
K884187 PHILLIP C. CRAWFORD, D.D.S. INDENTEC DRILL RA #1 12/22/1988
K896149 SIGNATURE ONE PRODUCTS, INC. ANEST-EZE DENTAL DRILL RA#2 01/19/1990
K905418 THE HYGENIC CORP. GATES GLIDDEN DRILLS 07/25/1991
K954790 TULSA DENTAL PRODUCTS, LTD. PROFILE NICKEL TITANIUM ROTARY INSTRUMENTS 01/16/1996
K984508 W & H DENTALWERK BUERMOOS GMBH SURGICAL CONTRA-ANGLE HANDPIECES, MODELS 975 AE,979 E/KM, 985 AE, 986 AE, 988 E/KM AND SURGICAL STRAIGHT HANDPIECES MOD 06/25/1999


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