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510(k) K890910

PLAKOF by Ximex, Ltd. — Product Code JET

K890910 is an FDA 510(k) premarket notification submitted by Ximex, Ltd. for the device "PLAKOF". The FDA issued a decision of Substantially Equivalent on March 16, 1989. The device falls under product code JET (Pick, Massaging), a Class I device regulated under 21 CFR 872.6650.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 1989
Date Received
February 23, 1989
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 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)
  • 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)
  • K850775 — DENTAL MASSAGING PICKS (April 10, 1985)

FDA data resources