Home / 510(k) Clearances / K911418

510(k) K911418

GUM MASSAGER by Burn-Henderson Partnership — Product Code JET

K911418 is an FDA 510(k) premarket notification submitted by Burn-Henderson Partnership for the device "GUM MASSAGER". The FDA issued a decision of Substantially Equivalent on July 17, 1991. 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
July 17, 1991
Date Received
April 1, 1991
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)
  • 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