Medical Device Manufacturer · US , Salt Lake City , UT

Ultradent Products, Inc. - FDA 510(k) Cleared Devices

104 submissions · 104 cleared · Since 1992

Recent clearances: Transcend Bulk Fill Flowable Composite, UltraEZ, Peak Universal Bond

Official Website

104

Total

104

Cleared

0

Denied

FDA 510(k) Regulatory Record - Ultradent Products, Inc. Dental ✕

104 devices

1-12 of 104

Cleared Jul 01, 2026

Transcend Bulk Fill Flowable Composite

Cleared Apr 30, 2026

Cleared Mar 20, 2024

Peak Universal Bond

Cleared Mar 15, 2024

FORMA Composite (Shade A3D)

Cleared Jul 01, 2022

Cleared Feb 22, 2022

VALO X, VALO X Accessory Lenses

Cleared Oct 13, 2021

Cleared Jul 13, 2021

UltraTemp Rez II

Cleared Mar 01, 2021

VALO Grand Corded and Accessory Lenses

Cleared Apr 29, 2019

VALO Grand Corded

Cleared Feb 09, 2018

ChlorCid, ChlorCid V, ChlorCid Surf

Cleared Jul 13, 2016

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Data Source

Sourced from the FDA 510(k) public files . 175,730 total devices indexed.

Last updated: Aug 06, 2026