510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K050612Substantially Equivalent

Lightspeed Cordless Endodontic Handpiece

Lightspeed Technology, Inc., San Antonio TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K050612 is the FDA 510(k) clearance record for LIGHTSPEED CORDLESS ENDODONTIC HANDPIECE, a class I device, cleared for Lightspeed Technology, Inc. on under FDA product code EKX (Handpiece, Direct Drive, Ac-Powered). FDA records list one 510(k) clearance for Lightspeed Technology, Inc. As of , FDA records show no recalls naming K050612.

Clearance record

Decision date
Received
(55 days to decision)
Product code
EKX Handpiece, Direct Drive, Ac-Powered
Regulation
21 CFR 872.4200
Device class
Class I
Review panel
Dental
Applicant
Lightspeed Technology, Inc. 403 E. Ramsey, Suite 205, San Antonio TX
510(k) summary
Statement
Third party review
No

Clearances, product code EKX

Trailing 12 months
1 clearance under product code EKX in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code EKX, 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 20261
October 20260