510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K914003Substantially Equivalent

Midas Bracket

Gold'N Braces, Inc., Palm Harbor FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K914003 is the FDA 510(k) clearance record for MIDAS BRACKET, a class I device, cleared for Gold'N Braces, Inc. on under FDA product code EJF (Bracket, Metal, Orthodontic). FDA records list one 510(k) clearance for Gold'N Braces, Inc. As of , FDA records show no recalls naming K914003.

Clearance record

Decision date
Received
(101 days to decision)
Product code
EJF Bracket, Metal, Orthodontic
Regulation
21 CFR 872.5410
Device class
Class I
Review panel
Dental
Applicant
Gold'N Braces, Inc. 2595 State Rd. 584, Suite 1, Palm Harbor 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