510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K020009Substantially Equivalent

Brace Eze

Udent, Inc., Pomona CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K020009 is the FDA 510(k) clearance record for BRACE EZE, a class I device, cleared for Udent, Inc. on under FDA product code EGD (Wax, Dental, Intraoral). FDA records list one 510(k) clearance for Udent, Inc. As of , FDA records show no recalls naming K020009.

Clearance record

Decision date
Received
(40 days to decision)
Product code
EGD Wax, Dental, Intraoral
Regulation
21 CFR 872.6890
Device class
Class I
Review panel
Dental
Applicant
Udent, Inc. 676 Fairplex Dr., Pomona CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EGD

Trailing 12 months

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

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