EFS — Unit, Oral Irrigation Class I

FDA Device Classification

Classification Details

Product Code
EFS
Device Class
Class I
Regulation Number
872.6510
Submission Type
Review Panel
DE
Medical Specialty
Dental
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K023232smartpracticeSPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLEDecember 11, 2002
K001493air forceDENTAL AIR FORCE HOME DENTAL CLEANING SYSTEM, MODEL NO. 0020001October 25, 2000
K983374midian intlAGATHA-A-H2010December 23, 1998
K964810ultradent productsDERMADAMFebruary 10, 1997
K952234cottrellBARRIER ALL FILMJuly 31, 1995
K943182oral-b laboratoriesORAL-B PERIOFLEX SUBGINGIVAL IRRIGATORSeptember 9, 1994
K923711novadentPERIOFLEX TIPMay 16, 1994
K923937hydro flossHYDRO FLOSSFebruary 25, 1994
K931380teledyne water pikWATER PIK PLUS PLAQUE CONTROL SYSTEMSeptember 20, 1993
K923457summit marketing groupSHOWERFLOSSSeptember 1, 1992
K922307showerflossSHOWERFLOSS ORAL IRRIGATION UNITJune 16, 1992
K921999bausch and lombINTERJET(TM) GINGIVAL CARE INSTRUMENTJune 3, 1992
K913030smith and nephewMAX-I-PROBE IRRIGATION SYSTEMSeptember 30, 1991
K910832oxyfreshOXYFRESH OXYCARE 3000April 17, 1991
K901955colgate-palmolivePERIOGARD(R) PERIOPENApril 15, 1991
K905188teledyne water pikPERIO PIKFebruary 15, 1991
K904850micro motorsDUAL AND SINGLE IRR. SYSTEMS MODELS 29550 & 29555January 25, 1991
K897053james r. powellL'LL SQUIRT GUM ORAL RINSE DEVICEAugust 6, 1990
K901600collagenOSSEOTITE IRRIGATION UNITJune 21, 1990
K900547teledyne water pikWATER PIK(R) W/ADD'L CLAIMSJune 15, 1990