510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K871784Substantially Equivalent

Top Form II Trays, Dispos Foam-Lined Top Gel Appli

Colgate-Hoyt Laboratories, Canton MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K871784 is the FDA 510(k) clearance record for TOP FORM II TRAYS, DISPOS FOAM-LINED TOP GEL APPLI, a class I device, cleared for Colgate-Hoyt Laboratories on under FDA product code KMT (Tray, Fluoride, Disposable). FDA records list one 510(k) clearance for Colgate-Hoyt Laboratories. As of , FDA records show no recalls naming K871784.

Clearance record

Decision date
Received
(21 days to decision)
Product code
KMT Tray, Fluoride, Disposable
Regulation
21 CFR 872.6870
Device class
Class I
Review panel
Dental
Applicant
Colgate-Hoyt Laboratories One Colgate Way, Canton MA
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