510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K905640Substantially Equivalent

Solid Core Gutta Percha Carrier

The Hygenic Company, LLC, Akron OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K905640 is the FDA 510(k) clearance record for SOLID CORE GUTTA PERCHA CARRIER, a class I device, cleared for The Hygenic Corp. on under FDA product code EKS (File, Pulp Canal, Endodontic). FDA records list 16 510(k) clearances for The Hygenic Corp., from to . As of , FDA records show no recalls naming K905640.

Clearance record

Decision date
Received
(78 days to decision)
Product code
EKS File, Pulp Canal, Endodontic
Regulation
21 CFR 872.4565
Device class
Class I
Review panel
Dental
Applicant
The Hygenic Corp. 1245 Home Ave., Akron OH
Third party review
No

Clearances, product code EKS

Trailing 12 months

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

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