FDA 510(k) Applications Submitted by ULTRADENT PRODUCTS, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K220471 02/18/2022 VALO X, VALO X Accessory Lenses Ultradent Products, Inc.
K211905 06/21/2021 UltraCal XS Ultradent Products, Inc.
K964808 11/29/1996 SPETEMP ULTRADENT PRODUCTS, INC.
K970114 01/13/1997 ULTRACAL XS ULTRADENT PRODUCTS, INC.
K970113 01/13/1997 ULTRA-BLEND PLUS ULTRADENT PRODUCTS, INC.
K980726 02/24/1998 ULTRA-BLASTER ULTRADENT PRODUCTS, INC.
K971284 04/07/1997 OPALDAM ULTRADENT PRODUCTS, INC.
K981596 05/04/1998 ULTRAPAK E ULTRADENT PRODUCTS, INC.
K971899 05/22/1997 ENDO-SEAL ULTRADENT PRODUCTS, INC.
K971898 05/22/1997 PERMALUTE, TRY-IN PASTE ULTRADENT PRODUCTS, INC.
K974283 11/14/1997 PQ 1 ULTRADENT PRODUCTS, INC.
K974282 11/14/1997 VITALESCENCE ULTRADENT PRODUCTS, INC.
K974413 11/24/1997 PERMAFLO ULTRADENT PRODUCTS, INC.
K964810 11/29/1996 DERMADAM ULTRADENT PRODUCTS, INC.
K964809 11/29/1996 SPETEMP EF ULTRADENT PRODUCTS, INC.
K974786 12/22/1997 PREPQUICK ULTRADENT PRODUCTS, INC.
K965060 12/18/1996 ULTRA-ETCH STAT ULTRADENT PRODUCTS, INC.
K071106 04/19/2007 ENDOREZ OBTURATION KIT (WITH ACCELERATOR), MODEL 403, ENDOREZ ACCELERATOR (REFILL), MODEL 399 ULTRADENT PRODUCTS, INC.
K111836 06/29/2011 PERMASHADE VENEER CEMENT ULTRADENT PRODUCTS, INC.
K152064 07/24/2015 Astringedent Clear ULTRADENT PRODUCTS, INC.
K173163 09/29/2017 ChlorCid, ChlorCid V, ChlorCid Surf Ultradent Products, Inc.
K063703 12/13/2006 CITRIC ACID 20% SOLUTION, MODEL 329 ULTRADENT PRODUCTS, INC.
K963979 10/03/1996 ULTRADENT UNIVERSAL DENTIN SEALANT ULTRADENT PRODUCTS, INC.
K080249 01/31/2008 FLOR-OPAL VARNISH WHITE; MODELS 4503, 4504, 4506, S4505 ULTRADENT PRODUCTS, INC.
K100301 02/03/2010 OPAL BOND FLOW ULTRADENT PRODUCTS, INC.
K090355 02/11/2009 OPAL SEAL ULTRADENT PRODUCTS, INC.
K110582 03/01/2011 VALO CORDLESS ULTRADENT PRODUCTS, INC.
K100752 03/17/2010 PEAK UNIVERSAL BOND (LIGHT CURE RESIN ADHESIVE AND CHLORHEXIDINE) ULTRADENT PRODUCTS, INC.
K080768 03/18/2008 ULTRATEMP FIRM, FAST AND REGULAR SET ULTRADENT PRODUCTS, INC.
K111017 04/12/2011 CLEARTEMP ULTRADENT PRODUCTS, INC.
K101245 05/04/2010 ULTRASEAL ID ULTRADENT PRODUCTS, INC.
K131357 05/10/2013 PEAK Z ULTRADENT PRODUCTS, INC.
K111696 06/17/2011 OPAL BAND CEMENT ULTRADENT PRODUCTS, INC.
K112517 08/31/2011 ULTRASEAL XT HYDRO ULTRADENT PRODUCTS, INC.
K063558 11/27/2006 PEAK SE, MODEL 5135 ULTRADENT PRODUCTS, INC.
K063557 11/27/2006 PEAK BOND, MODEL 5133 ULTRADENT PRODUCTS, INC.
K083647 12/09/2008 VALO, MODEL 5919 ULTRADENT PRODUCTS, INC.
K094006 12/28/2009 OPAL BOND MV ULTRADENT PRODUCTS, INC.
K190627 03/12/2019 VALO Grand Corded Ultradent Products, Inc.
K151094 04/23/2015 Mosaic Universal Composite ULTRADENT PRODUCTS, INC.
K123215 10/15/2012 VISCOSTAT CLEAR ULTRADENT PRODUCTS, INC.
K960697 02/20/1996 ULTRACID AND ULTRACID F DISINFECTING SOLUTION ULTRADENT PRODUCTS, INC.
K960696 02/20/1996 PERMALUTE COMPOSITE LUTING/RESTORATIVE RESIN SYSTEM ULTRADENT PRODUCTS, INC.
K160551 02/29/2016 VALO Grand ULTRADENT PRODUCTS, INC.
K023042 09/12/2002 PQ1 ULTRADENT PRODUCTS, INC.
K010070 01/08/2001 ULTRAPAK NEHA ULTRADENT PRODUCTS, INC.
K003383 10/31/2000 PALMLIGHT ULTRADENT PRODUCTS, INC.
K221909 06/30/2022 J-Temp Ultradent Products, Inc.
K032625 08/26/2003 ORTHODONTIC COMPOSITE BRACKET SYSTEM ULTRADENT PRODUCTS, INC.
K032627 08/26/2003 ULTRADENT CITRIC ACID 10% SOLUTION ULTRADENT PRODUCTS, INC.
K032626 08/26/2003 PERMAQUICK SE BONDING SYSTEM ULTRADENT PRODUCTS, INC.
K071055 04/16/2007 OPAL PRIME & OPAL BOND/ORTHODONTIC BRACKET SYSTEM, MODELS 2626, 2625, 2635, 2803, 2802 ULTRADENT PRODUCTS, INC.
K000189 01/21/2000 PQ1 ULTRADENT PRODUCTS, INC.
K992097 06/21/1999 ENDOREZ ULTRADENT PRODUCTS, INC.
K992380 07/16/1999 ENDO-EZE MOTOR AND HANDPIECE ULTRADENT PRODUCTS, INC.
K983668 10/19/1998 MODIFICATION OF PQ1 ULTRADENT PRODUCTS, INC.
K993846 11/12/1999 ULTRASEAL XT PLUS ULTRADENT PRODUCTS, INC.
K994261 12/17/1999 ULTRATEMP TEMPORARY POLYCARBOXYLATE CEMENT ULTRADENT PRODUCTS, INC.
K211237 04/26/2021 UltraTemp Rez II Ultradent Products, Inc.
K060335 02/09/2006 FILE-EZE ULTRADENT PRODUCTS, INC.
K060334 02/09/2006 GI DENTSTAT ULTRADENT PRODUCTS, INC.
K050730 03/21/2005 MODIFICATION TO ORTHODONTIC COMPOSITE BRACKET SYSTEM ULTRADENT PRODUCTS, INC.
K061438 05/24/2006 ULTRAEZ DESENSITIZING GEL ULTRADENT PRODUCTS, INC.
K051750 06/29/2005 FLOR-OPAL VARNISH, MODELS UP 4500/ UP 4501/ UP 4502 ULTRADENT PRODUCTS, INC.
K042583 09/22/2004 CALC-I-OSS ULTRADENT PRODUCTS, INC.
K042756 10/04/2004 ENDOREZ ULTRADENT PRODUCTS, INC.
K043119 11/10/2004 AMELOGEN PLUS ULTRADENT PRODUCTS, INC.


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