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510(k) K780712

KERR DISCOVERY DISPOSABLE FLUORIDE TRAY by Kerr Corporation (Danbury) — Product Code KMT

K780712 is an FDA 510(k) premarket notification submitted by Kerr Corporation (Danbury) for the device "KERR DISCOVERY DISPOSABLE FLUORIDE TRAY". The FDA issued a decision of Substantially Equivalent on May 17, 1978. The device falls under product code KMT (Tray, Fluoride, Disposable), a Class I device regulated under 21 CFR 872.6870. Kerr Corporation (Danbury) has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 1978
Date Received
April 26, 1978
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 by Kerr Corporation (Danbury)

  • K051545 — L.E. DEMETRON II (July 18, 2005)
  • K020091 — OPTILUX 501 (March 21, 2002)
  • K951663 — TYTIN R (June 6, 1995)
  • K951511 — TYTIN ADMIX (May 2, 1995)
  • K942480 — M4 CONTRA-ANGLE HANDPIECE (January 27, 1995)
  • K940513 — OPTIBOND (April 15, 1994)
  • K935535 — TYTIN (March 11, 1994)
  • K934690 — KERR OPTIBOND, MODIFICATION (December 30, 1993)
  • K923546 — OPTIBOND (September 29, 1992)
  • K915847 — AUTOMIX DENTAL AMALGAMATOR (March 2, 1992)

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)
  • K853882 — SUPER SLICK (November 18, 1985)
  • K820104 — NUPRO* GEL TRAY (February 23, 1982)
  • K811154 — HOYT ECONO-TRAY (May 13, 1981)
  • K770064 — FLUORIDE GEL DISPOSABLE TRAY (January 14, 1977)

FDA data resources