510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K073369Substantially Equivalent

Ei Downpak Barrier Sleeves

HU-Friedy Mfg. Co. LLC, Chicago IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K073369 is the FDA 510(k) clearance record for EI DOWNPAK BARRIER SLEEVES, a class I device, cleared for Hu-Friedy Mfg. Co., Inc. on under FDA product code EKM (Gutta-Percha). FDA records list 9 510(k) clearances for Hu-Friedy Mfg. Co., Inc., from to . As of , FDA records show no recalls naming K073369.

Clearance record

Decision date
Received
(89 days to decision)
Product code
EKM Gutta-Percha
Regulation
21 CFR 872.3850
Device class
Class I
Review panel
Dental
Applicant
Hu-Friedy Mfg. Co., Inc. 3232 N Rockwell St., Chicago IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EKM

Trailing 12 months

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

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