510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K930452Substantially Equivalent

Solo Ties

Zulaf, Inc., Lubbuck TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K930452 is the FDA 510(k) clearance record for SOLO TIES, a class I device, cleared for Zulaf, Inc. on under FDA product code EJF (Bracket, Metal, Orthodontic). FDA records list one 510(k) clearance for Zulaf, Inc. As of , FDA records show no recalls naming K930452.

Clearance record

Decision date
Received
(162 days to decision)
Product code
EJF Bracket, Metal, Orthodontic
Regulation
21 CFR 872.5410
Device class
Class I
Review panel
Dental
Applicant
Zulaf, Inc. P.O. Box 6661, Lubbuck TX
510(k) summary
Statement
Third party review
No

Clearances, product code EJF

Trailing 12 months

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

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