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510(k) K821629

FIXIDENT by Moyco Industries, Inc. — Product Code JET

K821629 is an FDA 510(k) premarket notification submitted by Moyco Industries, Inc. for the device "FIXIDENT". The FDA issued a decision of Substantially Equivalent on June 14, 1982. The device falls under product code JET (Pick, Massaging), a Class I device regulated under 21 CFR 872.6650. Moyco Industries, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 1982
Date Received
June 2, 1982
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 Moyco Industries, Inc.

  • K932511 — SILICONE MIRROR (November 5, 1993)
  • K833558 — X-RAY SHIELD (January 13, 1984)
  • K821444 — COLORED WEDGE USED TO SEPARATE TEETH (June 14, 1982)
  • K810839 — SPOTAR (April 29, 1981)
  • K810912 — ALLOY COMPOSITE POLISH (April 23, 1981)

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