Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ivoclar Vivadent, AG — Predicate Candidate Screening
31 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
111 daysmedian FDA review time
296 days90th percentile
31clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K210804 | Adhese Universal DC, Cention Primer | Ivoclar Vivadent, AG | 2022-06-07 | 447 | 0 |
| K211916 | IPS e.max One | Ivoclar Vivadent, AG | 2021-08-20 | 60 | 0 |
| K193193 | Telio CAD Abutment Solutions- extra systems | Ivoclar Vivadent, AG | 2020-11-16 | 363 | 0 |
| K191453 | Cervitec F | Ivoclar Vivadent, AG | 2020-02-11 | 256 | 0 |
| K191448 | Barrier Sleeves | Ivoclar Vivadent, AG | 2019-10-08 | 130 | 0 |
| K191382 | IPS e.max CAD Abutment Solutions- extra systems | Ivoclar Vivadent, AG | 2019-08-26 | 95 | 0 |
| K190339 | Helioseal F Plus | Ivoclar Vivadent, AG | 2019-07-29 | 165 | 0 |
| K190272 | Bluephase PowerCure | Ivoclar Vivadent, AG | 2019-07-03 | 145 | 0 |
| K183380 | Tetric PowerFill | Ivoclar Vivadent, AG | 2019-03-14 | 98 | 0 |
| K173573 | Tetric CAD | Ivoclar Vivadent, AG | 2018-06-07 | 199 | 0 |
| K163613 | Bluephase Style 20i | Ivoclar Vivadent, AG | 2017-04-04 | 103 | 0 |
| K160798 | IPS e.max® Press Abutment Solutions for Viteo Base Ti | Ivoclar Vivadent, AG | 2016-12-15 | 267 | 0 |
| K152103 | IPS Style Ceram, IPS Style Ceram One, IPS Style Press | Ivoclar Vivadent, AG | 2016-05-20 | 296 | 0 |
| K151894 | IPS Ivocolor | Ivoclar Vivadent, AG | 2015-10-29 | 111 | 0 |
| K151564 | Telio CAD Abutment Solutions | Ivoclar Vivadent, AG | 2015-09-21 | 103 | 0 |
| K150393 | TETRIC EVOFLOW BULK FILL | Ivoclar Vivadent, AG | 2015-06-09 | 111 | 0 |
| K150164 | Monobond Etch & Prime | Ivoclar Vivadent, AG | 2015-04-03 | 67 | 0 |
| K142389 | Variolink Esthetic | Ivoclar Vivadent, AG | 2014-11-25 | 90 | 0 |
| K131487 | FLUOR PROTECTOR S | Ivoclar Vivadent, AG | 2014-10-08 | 503 | 0 |
| K133318 | ADHESE UNIVERSAL | Ivoclar Vivadent, AG | 2014-02-11 | 106 | 0 |
| K132209 | IPS E.MAX CAD ABUTMENT SOLUTIONS | Ivoclar Vivadent, AG | 2013-10-31 | 107 | 0 |
| K130436 | MULTILINK HYBRID ABUTMENT CEMENT | Ivoclar Vivadent, AG | 2013-08-20 | 180 | 0 |
| K123397 | MULTILINK AUTOMIX | Ivoclar Vivadent, AG | 2013-01-31 | 87 | 0 |
| K123304 | SR NEXCO PASTE LAYERING MATERIALS, SR NEXCO OPAQUER, SR NEXC | Ivoclar Vivadent, AG | 2013-01-24 | 92 | 0 |
| K120053 | IPS E.MAX PRESS - ABUTMENT SOLUTIONS | Ivoclar Vivadent, AG | 2012-10-18 | 286 | 0 |
| K121230 | IPS EMPRESS DIRECT COLOR IPS EMPRESS DIRECT OPAQUE | Ivoclar Vivadent, AG | 2012-08-29 | 127 | 0 |
| K121359 | IPS 99 ONE AND IPS 99 CERAM | Ivoclar Vivadent, AG | 2012-07-27 | 81 | 0 |
| K120134 | IPS E.MAX PRESS MULTI | Ivoclar Vivadent, AG | 2012-06-25 | 160 | 0 |
| K120432 | TELIO CS CEM IMPLANT | Ivoclar Vivadent, AG | 2012-06-08 | 116 | 0 |
| K120736 | SR PHONARES II | Ivoclar Vivadent, AG | 2012-05-14 | 66 | 0 |
| K033773 | CONCEPT HP ADD-ON; CONCEPT HP ENAMEL | Ivoclar Vivadent, AG | 2004-01-15 | 43 | 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