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510(k) K770064

FLUORIDE GEL DISPOSABLE TRAY by Lorvic Corp. — Product Code KMT

K770064 is an FDA 510(k) premarket notification submitted by Lorvic Corp. for the device "FLUORIDE GEL DISPOSABLE TRAY". The FDA issued a decision of Substantially Equivalent on January 14, 1977. The device falls under product code KMT (Tray, Fluoride, Disposable), a Class I device regulated under 21 CFR 872.6870. Lorvic Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 1977
Date Received
January 11, 1977
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 Lorvic Corp.

  • K871615 — U. V. GERMICIDAL UNIT (September 11, 1987)
  • K780263 — SHIELD (May 3, 1978)
  • K770063 — DISP. ABSORBENT COMPRESSED FIBRE WAFER (January 14, 1977)
  • K760620 — SALIVA EJECTOR (September 21, 1976)
  • K760121 — IMPULSE HEAT SEALER (July 16, 1976)

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)
  • K780712 — KERR DISCOVERY DISPOSABLE FLUORIDE TRAY (May 17, 1978)

FDA data resources