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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