FDA 510(k) Applications for Medical Device Product Code "DYN"
(Mouthpiece, Saliva Ejector)

FDA 510(k) Number Applicant Device Name Decision Date
K863163 AMERICAN INSTRUMENT MANUFACTURER'S, INC. ULS 8-86 09/22/1986
K864300 ARDENT INTL., INC. SILIVA EJECTOR/ORAL CAVITY EVACUATOR 11/24/1986
K935616 ASA INSTRUMENTS S.R.L. SALIVA EJECTOR DISPOSABLE 03/21/1994
K861934 CARLISLE LABORATORIES, INC. SALIVA EJECTOR 06/09/1986
K921117 DELSAN DENTAL SYSTEMS MINIDAM 05/05/1992
K871315 ENDOVATIONS ORAL ASPIRATOR 04/15/1987
K924211 GLENROE TECHNOLOGIES EJECTOR 03/31/1993
K781592 HENRY SCHEIN, INC. SURGICAL ASPIRATOR TIPS 12/04/1978
K920492 HYGOPLASTIC, INC. HIGH VAC 05/11/1992
K935758 J.H.ORSING AB HYGOFLEX SALIVA-EJECTOR 03/21/1994
K900631 KAB GLOVES UNLTD. SALIVA ABSORBER - DENTAL 04/04/1990
K760620 LORVIC CORP. SALIVA EJECTOR 09/21/1976
K870599 MILITARY ENGINEERING, INC. TIP, DENTAL SUCTION APPARATUS 03/23/1987
K801927 SLUMBER RESEARCH, INC. SILENTSLEEP 11/14/1980
K761264 SYNTEX CORP. OPTIONS FOR STAR DENTAL OPUS I 12/23/1976
K940769 TERRAFLEX DENTFLEX DISPLOSABLE DENTAL SALIVA EJECTOR 08/17/1994
K863768 THE MEDICAL GROUP, INC. SALIVA EJECTORS 10/27/1986
K800210 UNITEK CORP. TONGUE HOLDER/SALIVA EJECTOR 02/06/1980


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