KHR — Absorber, Saliva, Paper Class I

FDA Device Classification

FDA product code KHR covers "Absorber, Saliva, Paper", a Class I medical device regulated under 21 CFR 872.6050. Submissions are reviewed by the Dental panel. At least 10 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
KHR
Device Class
Class I
Regulation Number
872.6050
Submission Type
Review Panel
DE
Medical Specialty
Dental
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K980783irt managementSIMPLEX SALIVA ABSORBER/COLLECTOR, MODEL SSA-5April 21, 1998
K954068physician industriesGENERAL HYGIENE KITNovember 8, 1995
K953812remington medicalGAUZE SPONGEOctober 2, 1995
K891054dispomedNON-STERILE GAUZE SPONGEMay 1, 1989
K891354american orthodonticsORTHODONTIC COTTON ROLL HOLDERSApril 17, 1989
K890734microcopy, div. neo-floDRY TIPSMarch 10, 1989
K870383adriALGINATE WOOL FIBERApril 30, 1987
K850988e.h. medicalBOVO MOISTURE GUARDApril 16, 1985
K780400nice-pak productsDEN-Z-ORBMarch 27, 1978
K7719083mISO-SHIELD SALIVA ABSORBERSNovember 7, 1977