EHK — Cup, Prophylaxis Class I

FDA Device Classification

FDA product code EHK covers "Cup, Prophylaxis", a Class I medical device regulated under 21 CFR 872.6290. Submissions are reviewed by the Dental panel. At least 8 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
EHK
Device Class
Class I
Regulation Number
872.6290
Submission Type
Review Panel
DE
Medical Specialty
Dental
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K953628rolence enterprise co.PROPHY ANGLESeptember 29, 1995
K951016preventive technologiesDISPOSABLE PROPHYLAXIS ANGLEMay 2, 1995
K900507dentsply intlDISPOSABLE SCREW TYPE PROPHY BRUSHApril 10, 1990
K864059mission white dentalDENTAL PROPHY CUPS (VARIOUS TYPES)November 19, 1986
K803155teledyne denscoPROPHYLAXIS CUP.January 8, 1981
K790723young dental manufacturing co. 1PROPHYLAXIS CUPS AND POLISHERSJune 15, 1979
K780198ransom and randolphPROPHY CUPS, R&RFebruary 16, 1978
K770556dental control productsPRO-KUPMarch 24, 1977