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510(k) K832949

SANODENT DOUBLE-ENDED INTERDENTAL CLEAN by Coopercare, Inc. — Product Code JET

K832949 is an FDA 510(k) premarket notification submitted by Coopercare, Inc. for the device "SANODENT DOUBLE-ENDED INTERDENTAL CLEAN". The FDA issued a decision of Substantially Equivalent on October 4, 1983. The device falls under product code JET (Pick, Massaging), a Class I device regulated under 21 CFR 872.6650. Coopercare, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 1983
Date Received
September 2, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pick, Massaging
Device Class
Class I
Regulation Number
872.6650
Review Panel
DE
Submission Type

Other clearances by Coopercare, Inc.

  • K834283 — DENTSPLY G-106 CAVITRON ULTRASONIC (March 16, 1984)

Other clearances for product code JET

  • K963747 — REACH STIM-U-DENT PLAQUE REMOVERS WITH MICRODENT/REACH FLOSS STIKS WITH MICRODEN (December 16, 1996)
  • K942633 — ORAL-B INTERDENTAL WOODSTICKS WITH FLUORIDE (April 27, 1995)
  • K930178 — ELECTRO FLOSS (July 28, 1993)
  • K911418 — GUM MASSAGER (July 17, 1991)
  • K885189 — MASSAGING PICK FOR ORAL HYGIENE (March 17, 1989)
  • K890910 — PLAKOF (March 16, 1989)
  • K883225 — FLOSSIE (August 30, 1988)
  • K881900 — PERMA-PIC PLASTIC TOOTHPICK (June 1, 1988)
  • K881046 — SUPER PIK MASSAGING PICK FOR ORAL HYGIENE (May 13, 1988)
  • K860779 — ULTRAPROX, INTERPROXIMAL TOOTHBRUSH (April 2, 1986)

FDA data resources