510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K882309Substantially Equivalent

The Direction Dial

Lawhorn Innovations, Missoula MT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K882309 is the FDA 510(k) clearance record for THE DIRECTION DIAL, a class I device, cleared for Lawhorn Innovations on under FDA product code EKJ (Burnisher, Operative). FDA records list one 510(k) clearance for Lawhorn Innovations. As of , FDA records show no recalls naming K882309.

Clearance record

Decision date
Received
(20 days to decision)
Product code
EKJ Burnisher, Operative
Regulation
21 CFR 872.4565
Device class
Class I
Review panel
Dental
Applicant
Lawhorn Innovations 218 E. Front St., Suite 302, Missoula MT
Third party review
No

Clearances, product code EKJ

Trailing 12 months

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

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