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510(k) K881046

SUPER PIK MASSAGING PICK FOR ORAL HYGIENE by U.S. Dentek Corp. — Product Code JET

K881046 is an FDA 510(k) premarket notification submitted by U.S. Dentek Corp. for the device "SUPER PIK MASSAGING PICK FOR ORAL HYGIENE". The FDA issued a decision of Substantially Equivalent on May 13, 1988. The device falls under product code JET (Pick, Massaging), a Class I device regulated under 21 CFR 872.6650. U.S. Dentek Corp. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 1988
Date Received
March 11, 1988
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 U.S. Dentek Corp.

  • K961574 — TONGUE SCRAPPER (June 10, 1996)
  • K931360 — ELECTRIC TOOTH-BRUSH (July 13, 1993)
  • K892861 — DENTAL PIK (September 15, 1989)

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)
  • K860779 — ULTRAPROX, INTERPROXIMAL TOOTHBRUSH (April 2, 1986)
  • K850775 — DENTAL MASSAGING PICKS (April 10, 1985)

FDA data resources