510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K980995Substantially Equivalent

Plaq-Ataq-I

Ethicare, Ft. Lauderdale FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K980995 is the FDA 510(k) clearance record for PLAQ-ATAQ-I, a class I device, cleared for Ethicare on under FDA product code EFW (Toothbrush, Manual). FDA records list one 510(k) clearance for Ethicare. As of , FDA records show no recalls naming K980995.

Clearance record

Decision date
Received
(174 days to decision)
Product code
EFW Toothbrush, Manual
Regulation
21 CFR 872.6855
Device class
Class I
Review panel
Dental
Applicant
Ethicare P.O. Box 5027, Ft. Lauderdale FL
510(k) summary
Statement
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