Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

105 results for "Ultradent Products, Inc."
1–24 of 105
Search insights Median review: 74d Cleared: 100% Top manufacturer: Ultradent Products, Inc. Lead specialty: Dental
Cleared Jul 01, 2026
Transcend Bulk Fill Flowable Composite
K262228 · EBF
Ultradent Products, Inc.
Dental · 1d
Cleared Apr 30, 2026
UltraEZ
K261404 · LBH
Ultradent Products, Inc.
Dental · 1d
Cleared Mar 20, 2024
Peak Universal Bond
K240743 · KLE
Ultradent Products, Inc.
Dental · 2d
Cleared Mar 15, 2024
FORMA Composite (Shade A3D)
K240694 · EBF
Ultradent Products, Inc.
Dental · 1d
Cleared Jul 01, 2022
J-Temp
K221909 · EBF
Ultradent Products, Inc.
Dental · 1d
Cleared Feb 22, 2022
VALO X, VALO X Accessory Lenses
K220471 · EBZ
Ultradent Products, Inc.
Dental · 4d
Cleared Oct 13, 2021
UltraCal XS
K211905 · KIF
Ultradent Products, Inc.
Dental · 114d
Cleared Jul 13, 2021
UltraTemp Rez II
K211237 · EMA
Ultradent Products, Inc.
Dental · 78d
Cleared Mar 01, 2021
VALO Grand Corded and Accessory Lenses
K210550 · EBZ
Ultradent Products, Inc.
Dental · 4d
Cleared Apr 29, 2019
VALO Grand Corded
K190627 · EBZ
Ultradent Products, Inc.
Dental · 48d
Cleared Feb 09, 2018
ChlorCid, ChlorCid V, ChlorCid Surf
K173163 · KJJ
Ultradent Products, Inc.
Dental · 133d
Cleared Jul 13, 2016
VALO Grand
K160551 · EBZ
Ultradent Products, Inc.
Dental · 135d
Cleared Sep 24, 2015
Astringedent Clear
K152064 · MVL
Ultradent Products, Inc.
Dental · 62d
Cleared Jul 21, 2015
Mosaic Universal Composite
K151094 · EBF
Ultradent Products, Inc.
Dental · 89d
Cleared Sep 06, 2013
PEAK Z
K131357 · KLE
Ultradent Products, Inc.
Dental · 119d
Cleared Feb 05, 2013
VISCOSTAT CLEAR
K123215 · MVL
Ultradent Products, Inc.
Dental · 113d
Cleared Feb 03, 2012
AVEX CX2 AND AVEX CXI2 CERAMIC BRACKETS
K113334 · NJM
Opal Orthodontics by Ultradent...
Dental · 81d
Cleared Sep 23, 2011
ULTRASEAL XT HYDRO
K112517 · EBC
Ultradent Products, Inc.
Dental · 23d
Cleared Sep 16, 2011
PERMASHADE VENEER CEMENT
K111836 · EMA
Ultradent Products, Inc.
Dental · 79d
Cleared Sep 07, 2011
OPAL BAND CEMENT
K111696 · DYH
Ultradent Products, Inc.
Dental · 82d
Cleared Jun 06, 2011
CLEARTEMP
K111017 · EMA
Ultradent Products, Inc.
Dental · 55d
Cleared Apr 28, 2011
VALO CORDLESS
K110582 · EBZ
Ultradent Products, Inc.
Dental · 58d
Cleared Sep 17, 2010
ULTRASEAL ID
K101245 · EBC
Ultradent Products, Inc.
Dental · 136d
Cleared Jul 16, 2010
PEAK UNIVERSAL BOND (LIGHT CURE RESIN ADHESIVE AND CHLORHEXIDINE)
K100752 · KLE
Ultradent Products, Inc.
Dental · 121d