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510(k) K871784

TOP FORM II TRAYS, DISPOS FOAM-LINED TOP GEL APPLI by Colgate-Hoyt Laboratories — Product Code KMT

K871784 is an FDA 510(k) premarket notification submitted by Colgate-Hoyt Laboratories for the device "TOP FORM II TRAYS, DISPOS FOAM-LINED TOP GEL APPLI". The FDA issued a decision of Substantially Equivalent on May 27, 1987. 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
May 27, 1987
Date Received
May 6, 1987
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)
  • K853882 — SUPER SLICK (November 18, 1985)
  • 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