Home / 510(k) Clearances / K031809

510(k) K031809

PERIO PROTECT TRAY by Perio Protect, LLC — Product Code KMT

K031809 is an FDA 510(k) premarket notification submitted by Perio Protect, LLC for the device "PERIO PROTECT TRAY". The FDA issued a decision of Substantially Equivalent on January 23, 2004. 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
January 23, 2004
Date Received
June 12, 2003
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

  • K904914 — DENTAL VACUUM INJECTION TRAY (December 17, 1990)
  • 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