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510(k) K811154

HOYT ECONO-TRAY by Hoyt Laboratories — Product Code KMT

K811154 is an FDA 510(k) premarket notification submitted by Hoyt Laboratories for the device "HOYT ECONO-TRAY". The FDA issued a decision of Substantially Equivalent on May 13, 1981. The device falls under product code KMT (Tray, Fluoride, Disposable), a Class I device regulated under 21 CFR 872.6870. Hoyt Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 1981
Date Received
April 28, 1981
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 Hoyt Laboratories

  • K820738 — LUSTRALLOY (April 9, 1982)
  • K810830 — HOYT COTTON ROLLS (April 14, 1981)
  • K780834 — PREVI DENT PROPHYLAXIS MINT NDC (June 2, 1978)
  • K771881 — REPLICA BONDING AGENT (November 9, 1977)
  • K771883 — REPLICA ACID-ETCH (October 20, 1977)
  • K771882 — REPLICA DENTAL COMPOSITE-RADIOPAQUE (October 20, 1977)
  • K771880 — REPLICA DENTAL COMPOSIT (October 20, 1977)
  • K771184 — TOOTHBRUSH, ORTHODONTIC, #0126-0189-00 (July 15, 1977)
  • K771185 — PERIODONTIC TOOTHBRUSH, #0126-0190-00 (July 15, 1977)
  • K771183 — TOOTHBRUSH, PEDODONTIC, #0126-0188-00 (July 15, 1977)

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)
  • K780712 — KERR DISCOVERY DISPOSABLE FLUORIDE TRAY (May 17, 1978)
  • K770064 — FLUORIDE GEL DISPOSABLE TRAY (January 14, 1977)

FDA data resources