Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ivoclar Vivadent, Inc. — Predicate Candidate Screening
66 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
71 daysmedian FDA review time
132 days90th percentile
66clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261485 | Tetric plus Fill;Tetric plus Flow | Ivoclar Vivadent, Inc. | 2026-07-01 | 57 | 0 |
| K253953 | IPS e.max Zirconia | Ivoclar Vivadent, Inc. | 2026-03-10 | 90 | 0 |
| K252450 | Adhese 2 | Ivoclar Vivadent, Inc. | 2026-03-05 | 213 | 0 |
| K233995 | Ivotion Base Print | Ivoclar Vivadent, Inc. | 2024-02-23 | 67 | 0 |
| K153753 | TelioCAD Multi | Ivoclar Vivadent, Inc. | 2016-04-12 | 105 | 0 |
| K143575 | Accu-Dent XD Tray, Accu-Dent XD Syringe | Ivoclar Vivadent, Inc. | 2015-04-03 | 107 | 0 |
| K132984 | SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL S | Ivoclar Vivadent, Inc. | 2014-01-14 | 112 | 0 |
| K111958 | TETRIC EVOCERAM BULK FILL | Ivoclar Vivadent, Inc. | 2011-10-14 | 95 | 0 |
| K110756 | BLUEPHASE STYLE | Ivoclar Vivadent, Inc. | 2011-08-29 | 164 | 1 |
| K103556 | IPS E.MAX CAD CRYSTALL / CONNECT AND IPS E.MAX CAD CRYSTAL / | Ivoclar Vivadent, Inc. | 2011-04-13 | 132 | 0 |
| K103528 | IPS EMPRESS DIRECT FLOW | Ivoclar Vivadent, Inc. | 2011-02-25 | 87 | 0 |
| K103391 | IVOBASE HYBRID, IVOBASE HIGH IMPACT | Ivoclar Vivadent, Inc. | 2011-02-17 | 90 | 0 |
| K103379 | TELIO CS INLAY & TELIO CS ONLAY | Ivoclar Vivadent, Inc. | 2011-02-14 | 89 | 0 |
| K093744 | EXCITE F AND EXCITE DSC | Ivoclar Vivadent, Inc. | 2010-03-10 | 96 | 1 |
| K093708 | TELIO CAD | Ivoclar Vivadent, Inc. | 2010-03-10 | 98 | 0 |
| K093331 | SR PHONARES NHC | Ivoclar Vivadent, Inc. | 2010-01-28 | 94 | 0 |
| K090941 | ADHESE ONE F | Ivoclar Vivadent, Inc. | 2009-07-17 | 105 | 0 |
| K090704 | MULTILINK IMPLANT | Ivoclar Vivadent, Inc. | 2009-06-17 | 92 | 0 |
| K091020 | BLUEPHASE 20I | Ivoclar Vivadent, Inc. | 2009-06-12 | 64 | 0 |
| K091019 | SPEEDCEM | Ivoclar Vivadent, Inc. | 2009-06-04 | 56 | 0 |
| K090826 | MONOBOND PLUS | Ivoclar Vivadent, Inc. | 2009-05-11 | 46 | 0 |
| K090701 | EMPRESS DIRECT | Ivoclar Vivadent, Inc. | 2009-04-29 | 43 | 0 |
| K072338 | CERVITEC PLUS | Ivoclar Vivadent, Inc. | 2007-09-21 | 32 | 0 |
| K071848 | IPS INLINE POM SYSTEM | Ivoclar Vivadent, Inc. | 2007-08-30 | 56 | 0 |
| K070646 | ADHESE ONE | Ivoclar Vivadent, Inc. | 2007-05-11 | 64 | 0 |
| K062258 | GENESIS DIODE LASER | Ivoclar Vivadent, Inc. | 2007-03-21 | 229 | 0 |
| K062713 | ADHESIVE DC ACTIVATOR | Ivoclar Vivadent, Inc. | 2006-11-02 | 52 | 0 |
| K061781 | MULTILINK SPRINT | Ivoclar Vivadent, Inc. | 2006-09-05 | 71 | 0 |
| K060891 | VIRTUAL | Ivoclar Vivadent, Inc. | 2006-07-17 | 108 | 0 |
| K060565 | CONDYLAFORM II NFC | Ivoclar Vivadent, Inc. | 2006-05-08 | 66 | 0 |
| K060365 | APEXCAL | Ivoclar Vivadent, Inc. | 2006-04-17 | 63 | 0 |
| K051705 | IPS E.MAX CAD/IPS E.MAX ZIRCAD | Ivoclar Vivadent, Inc. | 2005-10-14 | 112 | 6 |
| K051782 | BLUEPHASE 16I | Ivoclar Vivadent, Inc. | 2005-09-20 | 81 | 0 |
| K050453 | ODYSSEY 2.4G, DENLASER ELITE, MODEL 002-00050 | Ivoclar Vivadent, Inc. | 2005-05-27 | 94 | 0 |
| K042846 | SYSTEMP.LINK | Ivoclar Vivadent, Inc. | 2004-12-20 | 66 | 0 |
| K042847 | SYSTEMP.CEM | Ivoclar Vivadent, Inc. | 2004-12-17 | 63 | 0 |
| K042820 | SYSTEMP.C&B PLUS | Ivoclar Vivadent, Inc. | 2004-12-14 | 63 | 0 |
| K042848 | FRC POSTEC PLUS | Ivoclar Vivadent, Inc. | 2004-11-22 | 38 | 0 |
| K042819 | TETRIC EVOCERAM | Ivoclar Vivadent, Inc. | 2004-11-09 | 28 | 0 |
| K041433 | BRIGHT GOLD XH | Ivoclar Vivadent, Inc. | 2004-08-19 | 83 | 0 |
| K040951 | SR ADORO | Ivoclar Vivadent, Inc. | 2004-05-19 | 37 | 0 |
| K040795 | MULTICORE HB; MULTICORE FLOW | Ivoclar Vivadent, Inc. | 2004-05-17 | 49 | 0 |
| K033520 | BLUEPHASE | Ivoclar Vivadent, Inc. | 2003-12-05 | 28 | 0 |
| K032470 | MULTILINK | Ivoclar Vivadent, Inc. | 2003-11-05 | 86 | 0 |
| K030922 | VIVASENS | Ivoclar Vivadent, Inc. | 2003-10-17 | 207 | 0 |
| K032715 | DW 296 #15 SOLDER | Ivoclar Vivadent, Inc. | 2003-09-26 | 24 | 0 |
| K032493 | ALEXANDER | Ivoclar Vivadent, Inc. | 2003-09-04 | 23 | 0 |
| K030435 | BIOUNIVERSAL PKF | Ivoclar Vivadent, Inc. | 2003-04-15 | 64 | 0 |
| K030436 | BIO UNIVERSAL | Ivoclar Vivadent, Inc. | 2003-04-15 | 64 | 0 |
| K024094 | 4 SEASONS | Ivoclar Vivadent, Inc. | 2003-02-14 | 65 | 0 |
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