510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K933080Substantially Equivalent

Orthotech Dura-Gold Barckets

Orthotech Co., Ltd., Tampa FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K933080 is the FDA 510(k) clearance record for ORTHOTECH DURA-GOLD BARCKETS, a class I device, cleared for Orthotech on under FDA product code EJF (Bracket, Metal, Orthodontic). FDA records list 2 510(k) clearances for Orthotech, from to . As of , FDA records show no recalls naming K933080.

Clearance record

Decision date
Received
(273 days to decision)
Product code
EJF Bracket, Metal, Orthodontic
Regulation
21 CFR 872.5410
Device class
Class I
Review panel
Dental
Applicant
Orthotech 5121 Ehrlich Rd., Tampa FL
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