510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K930086Substantially Equivalent

Ortholux Xt

3M Company, Monrovia CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K930086 is the FDA 510(k) clearance record for ORTHOLUX XT, a class II device, cleared for 3M Company on under FDA product code EBZ (Activator, Ultraviolet, For Polymerization). FDA records list 13 510(k) clearances for 3M Company, from to . As of , FDA records show no recalls naming K930086.

Clearance record

Decision date
Received
(106 days to decision)
Product code
EBZ Activator, Ultraviolet, For Polymerization
Regulation
21 CFR 872.6070
Device class
Class II
Review panel
Dental
Applicant
3M Company 2724 S. Peck Rd., Monrovia CA
510(k) summary
Summary
Third party review
No

Clearances, product code EBZ

Trailing 12 months
1 clearance under product code EBZ in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code EBZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260