510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K770367Substantially Equivalent

Root Canal Files & Reamers

Cemco Tool Co., Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K770367 is the FDA 510(k) clearance record for ROOT CANAL FILES & REAMERS, a class I device, cleared for Cemco Tool Co., Inc. on under FDA product code EKP (Reamer, Pulp Canal, Endodontic). FDA records list one 510(k) clearance for Cemco Tool Co., Inc. As of , FDA records show no recalls naming K770367.

Clearance record

Decision date
Received
(7 days to decision)
Product code
EKP Reamer, Pulp Canal, Endodontic
Regulation
21 CFR 872.4565
Device class
Class I
Review panel
Dental
Applicant
Cemco Tool Co., Inc. 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