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."
25–48 of 105
Search insights Median review: 74d Cleared: 100% Top manufacturer: Ultradent Products, Inc. Lead specialty: Dental
Cleared Apr 29, 2010
OPAL BOND FLOW
K100301 · DYH
Ultradent Products, Inc.
Dental · 85d
Cleared Mar 23, 2010
OPAL BOND MV
K094006 · DYH
Ultradent Products, Inc.
Dental · 85d
Cleared Apr 29, 2009
OPAL SEAL
K090355 · DYH
Ultradent Products, Inc.
Dental · 77d
Cleared Jan 23, 2009
VALO, MODEL 5919
K083647 · EBZ
Ultradent Products, Inc.
Dental · 45d
Cleared Apr 11, 2008
ULTRATEMP FIRM, FAST AND REGULAR SET
K080768 · EMA
Ultradent Products, Inc.
Dental · 24d
Cleared Feb 08, 2008
FLOR-OPAL VARNISH WHITE
K080249 · LBH
Ultradent Products, Inc.
Dental · 8d
Cleared Jun 12, 2007
ULTRAEZ DESENSITIZING GEL
K061438 · LBH
Ultradent Products, Inc.
Dental · 384d
Cleared May 08, 2007
ENDOREZ OBTURATION KIT (WITH ACCELERATOR), MODEL 403, ENDOREZ ACCELERATOR...
K071106 · KIF
Ultradent Products, Inc.
Dental · 19d
Cleared May 03, 2007
OPAL PRIME & OPAL BOND/ORTHODONTIC BRACKET SYSTEM, MODELS 2626, 2625, 2635,...
K071055 · DYW
Ultradent Products, Inc.
Dental · 17d
Cleared Dec 21, 2006
CITRIC ACID 20% SOLUTION, MODEL 329
K063703 · KJJ
Ultradent Products, Inc.
Dental · 8d
Cleared Dec 14, 2006
PEAK SE, MODEL 5135
K063558 · KLE
Ultradent Products, Inc.
Dental · 17d
Cleared Dec 12, 2006
PEAK BOND, MODEL 5133
K063557 · KLE
Ultradent Products, Inc.
Dental · 15d
Cleared Feb 24, 2006
FILE-EZE
K060335 · KJJ
Ultradent Products, Inc.
Dental · 15d
Cleared Feb 23, 2006
GI DENTSTAT
K060334 · EMA
Ultradent Products, Inc.
Dental · 14d
Cleared Sep 19, 2005
FLOR-OPAL VARNISH, MODELS UP 4500/ UP 4501/ UP 4502
K051750 · LBH
Ultradent Products, Inc.
Dental · 82d
Cleared Jul 19, 2005
CALC-I-OSS
K042583 · LYC
Ultradent Products, Inc.
Dental · 300d
Cleared Mar 31, 2005
MODIFICATION TO ORTHODONTIC COMPOSITE BRACKET SYSTEM
K050730 · DYW
Ultradent Products, Inc.
Dental · 10d
Cleared Dec 17, 2004
AMELOGEN PLUS
K043119 · EBF
Ultradent Products, Inc.
Dental · 37d
Cleared Oct 26, 2004
ENDOREZ
K042756 · KIF
Ultradent Products, Inc.
Dental · 22d
Cleared Feb 26, 2004
ORTHODONTIC COMPOSITE BRACKET SYSTEM
K032625 · DYW
Ultradent Products, Inc.
Dental · 184d
Cleared Dec 03, 2003
PERMAQUICK SE BONDING SYSTEM
K032626 · KLE
Ultradent Products, Inc.
Dental · 99d
Cleared Nov 12, 2003
ULTRADENT CITRIC ACID 10% SOLUTION
K032627 · KJJ
Ultradent Products, Inc.
Dental · 78d
Cleared Oct 28, 2002
PQ1
K023042 · KLE
Ultradent Products, Inc.
Dental · 46d
Cleared Mar 15, 2001
ULTRAPAK NEHA
K010070 · MVL
Ultradent Products, Inc.
Dental · 66d