510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K800291Substantially Equivalent

Endex Reamers Pulp Canal, Endodontic

Ipco Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K800291 is the FDA 510(k) clearance record for ENDEX REAMERS PULP CANAL, ENDODONTIC, a class I device, cleared for Ipco Corp. on under FDA product code EKP (Reamer, Pulp Canal, Endodontic). FDA records list 13 510(k) clearances for Ipco Corp., from to . As of , FDA records show no recalls naming K800291.

Clearance record

Decision date
Received
(8 days to decision)
Product code
EKP Reamer, Pulp Canal, Endodontic
Regulation
21 CFR 872.4565
Device class
Class I
Review panel
Dental
Applicant
Ipco Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code EKP

Trailing 12 months

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

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