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510(k) K963747

REACH STIM-U-DENT PLAQUE REMOVERS WITH MICRODENT/REACH FLOSS STIKS WITH MICRODENT/REACH FLOSS PICS WITH MICRODENT ETC. by Whitehill Manufacturing, Inc. — Product Code JET

K963747 is an FDA 510(k) premarket notification submitted by Whitehill Manufacturing, Inc. for the device "REACH STIM-U-DENT PLAQUE REMOVERS WITH MICRODENT/REACH FLOSS STIKS WITH MICRODENT/REACH FLOSS PICS WITH MICRODENT ETC.". The FDA issued a decision of Substantially Equivalent on December 16, 1996. 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
December 16, 1996
Date Received
September 17, 1996
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

  • 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)
  • K850775 — DENTAL MASSAGING PICKS (April 10, 1985)

FDA data resources