510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K801463Substantially Equivalent

Oj-1 Endodonic Root Canal File Holder

Almore Intl., Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K801463 is the FDA 510(k) clearance record for OJ-1 ENDODONIC ROOT CANAL FILE HOLDER, a class I device, cleared for Almore Intl., Inc. on under FDA product code EKQ (Preparer, Root Canal Endodontic). FDA records list 21 510(k) clearances for Almore Intl., Inc., from to . As of , FDA records show no recalls naming K801463.

Clearance record

Decision date
Received
(27 days to decision)
Product code
EKQ Preparer, Root Canal Endodontic
Regulation
21 CFR 872.4565
Device class
Class I
Review panel
Dental
Applicant
Almore Intl., Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code EKQ

Trailing 12 months

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

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