510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K811154Substantially Equivalent

Hoyt Econo-Tray

Hoyt Laboratories, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K811154 is the FDA 510(k) clearance record for HOYT ECONO-TRAY, a class I device, cleared for Hoyt Laboratories on under FDA product code KMT (Tray, Fluoride, Disposable). FDA records list 11 510(k) clearances for Hoyt Laboratories, from to . As of , FDA records show no recalls naming K811154.

Clearance record

Decision date
Received
(15 days to decision)
Product code
KMT Tray, Fluoride, Disposable
Regulation
21 CFR 872.6870
Device class
Class I
Review panel
Dental
Applicant
Hoyt Laboratories 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KMT

Trailing 12 months

FDA records hold no clearances under product code KMT in the trailing twelve months.

FDA records show no clearances under product code KMT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KMT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260