Ivoclar Vivadent, Inc.: FDA filings under this applicant name
FDA lists 66 510(k) clearances under the applicant name “Ivoclar Vivadent, Inc.” (first 2001, latest 2026), across 16 product codes in 2 review panels. Median 510(k) review time under this name: 69 days. Since 2017 the median was 78 days, against 105 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 112 |
| 2015 | 1 | 107 |
| 2016 | 1 | 105 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 67 |
| 2025 | 0 | — |
| 2026 | 3 | 90 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Ivoclar Vivadent, Inc. took a median 78 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 105 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | 9 | 9 |
| EJT | Alloy, Gold-Based Noble Metal | 7 | 7 |
| KLE | Agent, Tooth Bonding, Resin | 7 | 7 |
| EBG | Crown And Bridge, Temporary, Resin | 6 | 6 |
| EBZ | Activator, Ultraviolet, For Polymerization | 6 | 6 |
| EMA | Cement, Dental | 5 | 5 |
| EIH | Powder, Porcelain | 4 | 4 |
| EJS | Alloy, Other Noble Metal | 4 | 4 |
| ELM | Denture, Plastic, Teeth | 4 | 4 |
| EJH | Alloy, Metal, Base | 3 | 3 |
Plus 6 more product codes.
Review panels
- Dental (64)
- General and Plastic Surgery (2)
Most recent Ivoclar Vivadent, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261485 | Tetric plus Fill;Tetric plus Flow | EBF | 2026-07-01 | 57 |
| K253953 | IPS e.max Zirconia | EIH | 2026-03-10 | 90 |
| K252450 | Adhese 2 | KLE | 2026-03-05 | 213 |
| K233995 | Ivotion Base Print | EBI | 2024-02-23 | 67 |
| K153753 | TelioCAD Multi | EBG | 2016-04-12 | 105 |
| K143575 | Accu-Dent XD Tray, Accu-Dent XD Syringe | ELW | 2015-04-03 | 107 |
| K132984 | SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL S | ELM | 2014-01-14 | 112 |
| K111958 | TETRIC EVOCERAM BULK FILL | EBF | 2011-10-14 | 95 |
| K110756 | BLUEPHASE STYLE | EBZ | 2011-08-29 | 164 |
| K103556 | IPS E.MAX CAD CRYSTALL / CONNECT AND IPS E.MAX CAD CRYSTAL / ADD-ON CONNECT (FOR CAD-ON TECHNIQUE) | EIH | 2011-04-13 | 132 |
56 earlier clearances. See the full list in Caduvo.
Recalls
34 product recalls in 9 recall events; 1 initiated in the last five years. Most recent: 2023-12-21.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Ivoclar North America, Inc. (131 510(k)s)
- Ivoclar Vivadent, AG (31 510(k)s)
- Ivoclar USA, Inc. (11 510(k)s)
- Ivoclar Vivadent, Agin (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ivoclar Vivadent, Inc.?
FDA lists 66 510(k) clearances under the applicant name “Ivoclar Vivadent, Inc.” (first 2001, latest 2026), across 16 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ivoclar Vivadent, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ivoclar Vivadent, Inc. is 69 days. Since 2017: 78 days, versus 105 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Ivoclar Vivadent, Inc.?
The most frequent FDA product codes under this applicant name are EBF (Material, Tooth Shade, Resin, 9); EJT (Alloy, Gold-Based Noble Metal, 7); KLE (Agent, Tooth Bonding, Resin, 7).
Next steps
- See all 66 Ivoclar Vivadent, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EBF, Ivoclar Vivadent, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.