510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K020776Substantially Equivalent

Medoral Hygienic Toothbrush with Dentosan Filaments

Coronet Group North America, LLC, Queensbury, NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K020776 is the FDA 510(k) clearance record for MEDORAL HYGIENIC TOOTHBRUSH WITH DENTOSAN FILAMENTS, a class I device, cleared for Coronet Group North America, LLC on under FDA product code EFW (Toothbrush, Manual). FDA records list one 510(k) clearance for Coronet Group North America, LLC. As of , FDA records show no recalls naming K020776.

Clearance record

Decision date
Received
(84 days to decision)
Product code
EFW Toothbrush, Manual
Regulation
21 CFR 872.6855
Device class
Class I
Review panel
Dental
Applicant
Coronet Group North America, LLC 181 Dixion Rd., Queensbury, NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EFW

Trailing 12 months

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

FDA records show no clearances under product code EFW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EFW, 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