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510(k) K904914

DENTAL VACUUM INJECTION TRAY by The Lebanon Vac-Tray Corp. — Product Code KMT

K904914 is an FDA 510(k) premarket notification submitted by The Lebanon Vac-Tray Corp. for the device "DENTAL VACUUM INJECTION TRAY". The FDA issued a decision of Substantially Equivalent on December 17, 1990. 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
December 17, 1990
Date Received
October 31, 1990
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)
  • K871784 — TOP FORM II TRAYS, DISPOS FOAM-LINED TOP GEL APPLI (May 27, 1987)
  • 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