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510(k) K850775

DENTAL MASSAGING PICKS by L.A.K. Ent., Inc. — Product Code JET

K850775 is an FDA 510(k) premarket notification submitted by L.A.K. Ent., Inc. for the device "DENTAL MASSAGING PICKS". The FDA issued a decision of Substantially Equivalent on April 10, 1985. The device falls under product code JET (Pick, Massaging), a Class I device regulated under 21 CFR 872.6650. L.A.K. Ent., Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 1985
Date Received
February 26, 1985
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 L.A.K. Ent., Inc.

  • K850776 — PREFORMED DENTAL IMPRESSION TRAYS (March 18, 1985)

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