510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K133178Substantially Equivalent

Luxator Lx Handpiece

Directa AB, Upplands Vasby, SE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K133178 is the FDA 510(k) clearance record for LUXATOR LX HANDPIECE, a class I device, cleared for Directa AB on under FDA product code EGS (Handpiece, Contra- And Right-Angle Attachment, Dental). FDA records list one 510(k) clearance for Directa AB. As of , FDA records show no recalls naming K133178.

Clearance record

Decision date
Received
(768 days to decision)
Product code
EGS Handpiece, Contra- And Right-Angle Attachment, Dental
Regulation
21 CFR 872.4200
Device class
Class I
Review panel
Dental
Applicant
Directa AB P.O. Box 723, Upplands Vasby, SE
510(k) summary
Statement
Third party review
No

Clearances, product code EGS

Trailing 12 months

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

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