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510(k) K853882

SUPER SLICK by Tang Products — Product Code KMT

K853882 is an FDA 510(k) premarket notification submitted by Tang Products for the device "SUPER SLICK". The FDA issued a decision of Substantially Equivalent on November 18, 1985. The device falls under product code KMT (Tray, Fluoride, Disposable), a Class I device regulated under 21 CFR 872.6870.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 1985
Date Received
September 19, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tray, Fluoride, Disposable
Device Class
Class I
Regulation Number
872.6870
Review Panel
DE
Submission Type

Other clearances for product code KMT

  • K031809 — PERIO PROTECT TRAY (January 23, 2004)
  • K904914 — DENTAL VACUUM INJECTION TRAY (December 17, 1990)
  • K871784 — TOP FORM II TRAYS, DISPOS FOAM-LINED TOP GEL APPLI (May 27, 1987)
  • K820104 — NUPRO* GEL TRAY (February 23, 1982)
  • K811154 — HOYT ECONO-TRAY (May 13, 1981)
  • K780712 — KERR DISCOVERY DISPOSABLE FLUORIDE TRAY (May 17, 1978)
  • K770064 — FLUORIDE GEL DISPOSABLE TRAY (January 14, 1977)

FDA data resources