Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ultradent Products, Inc. · Predicate Candidate Screening
104 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
74 daysmedian FDA review time
169 days90th percentile
104clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K262228 | Transcend Bulk Fill Flowable Composite | Ultradent Products, Inc. | 2026-07-01 | 1 | 0 |
| K261404 | UltraEZ | Ultradent Products, Inc. | 2026-04-30 | 1 | 0 |
| K240743 | Peak Universal Bond | Ultradent Products, Inc. | 2024-03-20 | 2 | 0 |
| K240694 | FORMA Composite (Shade A3D) | Ultradent Products, Inc. | 2024-03-15 | 1 | 0 |
| K221909 | J-Temp | Ultradent Products, Inc. | 2022-07-01 | 1 | 0 |
| K220471 | VALO X, VALO X Accessory Lenses | Ultradent Products, Inc. | 2022-02-22 | 4 | 0 |
| K211905 | UltraCal XS | Ultradent Products, Inc. | 2021-10-13 | 114 | 0 |
| K211237 | UltraTemp Rez II | Ultradent Products, Inc. | 2021-07-13 | 78 | 0 |
| K210550 | VALO Grand Corded and Accessory Lenses | Ultradent Products, Inc. | 2021-03-01 | 4 | 0 |
| K190627 | VALO Grand Corded | Ultradent Products, Inc. | 2019-04-29 | 48 | 0 |
| K173163 | ChlorCid, ChlorCid V, ChlorCid Surf | Ultradent Products, Inc. | 2018-02-09 | 133 | 0 |
| K160551 | VALO Grand | Ultradent Products, Inc. | 2016-07-13 | 135 | 0 |
| K152064 | Astringedent Clear | Ultradent Products, Inc. | 2015-09-24 | 62 | 0 |
| K151094 | Mosaic Universal Composite | Ultradent Products, Inc. | 2015-07-21 | 89 | 0 |
| K131357 | PEAK Z | Ultradent Products, Inc. | 2013-09-06 | 119 | 0 |
| K123215 | VISCOSTAT CLEAR | Ultradent Products, Inc. | 2013-02-05 | 113 | 0 |
| K112517 | ULTRASEAL XT HYDRO | Ultradent Products, Inc. | 2011-09-23 | 23 | 0 |
| K111836 | PERMASHADE VENEER CEMENT | Ultradent Products, Inc. | 2011-09-16 | 79 | 0 |
| K111696 | OPAL BAND CEMENT | Ultradent Products, Inc. | 2011-09-07 | 82 | 0 |
| K111017 | CLEARTEMP | Ultradent Products, Inc. | 2011-06-06 | 55 | 0 |
| K110582 | VALO CORDLESS | Ultradent Products, Inc. | 2011-04-28 | 58 | 0 |
| K101245 | ULTRASEAL ID | Ultradent Products, Inc. | 2010-09-17 | 136 | 0 |
| K100752 | PEAK UNIVERSAL BOND (LIGHT CURE RESIN ADHESIVE AND CHLORHEXI | Ultradent Products, Inc. | 2010-07-16 | 121 | 0 |
| K100301 | OPAL BOND FLOW | Ultradent Products, Inc. | 2010-04-29 | 85 | 0 |
| K094006 | OPAL BOND MV | Ultradent Products, Inc. | 2010-03-23 | 85 | 0 |
| K090355 | OPAL SEAL | Ultradent Products, Inc. | 2009-04-29 | 77 | 0 |
| K083647 | VALO, MODEL 5919 | Ultradent Products, Inc. | 2009-01-23 | 45 | 0 |
| K080768 | ULTRATEMP FIRM, FAST AND REGULAR SET | Ultradent Products, Inc. | 2008-04-11 | 24 | 0 |
| K080249 | FLOR-OPAL VARNISH WHITE; MODELS 4503, 4504, 4506, S4505 | Ultradent Products, Inc. | 2008-02-08 | 8 | 0 |
| K061438 | ULTRAEZ DESENSITIZING GEL | Ultradent Products, Inc. | 2007-06-12 | 384 | 0 |
| K071106 | ENDOREZ OBTURATION KIT (WITH ACCELERATOR), MODEL 403, ENDORE | Ultradent Products, Inc. | 2007-05-08 | 19 | 0 |
| K071055 | OPAL PRIME & OPAL BOND/ORTHODONTIC BRACKET SYSTEM, MODELS 26 | Ultradent Products, Inc. | 2007-05-03 | 17 | 0 |
| K063703 | CITRIC ACID 20% SOLUTION, MODEL 329 | Ultradent Products, Inc. | 2006-12-21 | 8 | 0 |
| K063558 | PEAK SE, MODEL 5135 | Ultradent Products, Inc. | 2006-12-14 | 17 | 1 |
| K063557 | PEAK BOND, MODEL 5133 | Ultradent Products, Inc. | 2006-12-12 | 15 | 0 |
| K060335 | FILE-EZE | Ultradent Products, Inc. | 2006-02-24 | 15 | 0 |
| K060334 | GI DENTSTAT | Ultradent Products, Inc. | 2006-02-23 | 14 | 0 |
| K051750 | FLOR-OPAL VARNISH, MODELS UP 4500/ UP 4501/ UP 4502 | Ultradent Products, Inc. | 2005-09-19 | 82 | 0 |
| K042583 | CALC-I-OSS | Ultradent Products, Inc. | 2005-07-19 | 300 | 0 |
| K050730 | MODIFICATION TO ORTHODONTIC COMPOSITE BRACKET SYSTEM | Ultradent Products, Inc. | 2005-03-31 | 10 | 0 |
| K043119 | AMELOGEN PLUS | Ultradent Products, Inc. | 2004-12-17 | 37 | 0 |
| K042756 | ENDOREZ | Ultradent Products, Inc. | 2004-10-26 | 22 | 0 |
| K032625 | ORTHODONTIC COMPOSITE BRACKET SYSTEM | Ultradent Products, Inc. | 2004-02-26 | 184 | 0 |
| K032626 | PERMAQUICK SE BONDING SYSTEM | Ultradent Products, Inc. | 2003-12-03 | 99 | 0 |
| K032627 | ULTRADENT CITRIC ACID 10% SOLUTION | Ultradent Products, Inc. | 2003-11-12 | 78 | 0 |
| K023042 | PQ1 | Ultradent Products, Inc. | 2002-10-28 | 46 | 0 |
| K010070 | ULTRAPAK NEHA | Ultradent Products, Inc. | 2001-03-15 | 66 | 0 |
| K003383 | PALMLIGHT | Ultradent Products, Inc. | 2001-02-06 | 98 | 0 |
| K000189 | PQ1 | Ultradent Products, Inc. | 2000-05-11 | 111 | 0 |
| K993846 | ULTRASEAL XT PLUS | Ultradent Products, Inc. | 2000-02-16 | 96 | 1 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda