510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K952234Substantially Equivalent

Barrier All Film

Cottrell, Ltd., North Attleboro MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K952234 is the FDA 510(k) clearance record for BARRIER ALL FILM, a class I device, cleared for Cottrell, Ltd. on under FDA product code EFS (Unit, Oral Irrigation). FDA records list 9 510(k) clearances for Cottrell, Ltd., from to . As of , FDA records show no recalls naming K952234.

Clearance record

Decision date
Received
(80 days to decision)
Product code
EFS Unit, Oral Irrigation
Regulation
21 CFR 872.6510
Device class
Class I
Review panel
Dental
Applicant
Cottrell, Ltd. 49 Plain St., North Attleboro MA
510(k) summary
Summary
Third party review
No

Clearances, product code EFS

Trailing 12 months

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

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