510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K032625Substantially Equivalent

Orthodontic Composite Bracket System

Ultradent Products Inc., South Jordan UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K032625 is the FDA 510(k) clearance record for ORTHODONTIC COMPOSITE BRACKET SYSTEM, a class II device, cleared for Ultradent Products, Inc. on under FDA product code DYW (Bracket, Plastic, Orthodontic). FDA records list 104 510(k) clearances for Ultradent Products, Inc., from to . As of , FDA records show no recalls naming K032625.

Clearance record

Decision date
Received
(184 days to decision)
Product code
DYW Bracket, Plastic, Orthodontic
Regulation
21 CFR 872.5470
Device class
Class II
Review panel
Dental
Applicant
Ultradent Products, Inc. 505 W. 10200 S., South Jordan UT
510(k) summary
Statement
Third party review
No

Clearances, product code DYW

Trailing 12 months
1 clearance under product code DYW in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DYW, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260