Ivoclar North America, Inc.: FDA filings under this applicant name
FDA lists 131 510(k) clearances under the applicant name “Ivoclar North America, Inc.” (first 1989, latest 2001), across 25 product codes in 1 review panel. Median 510(k) review time under this name: 52 days. 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 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EJT | Alloy, Gold-Based Noble Metal | 29 | 29 |
| EBF | Material, Tooth Shade, Resin | 28 | 28 |
| EJS | Alloy, Other Noble Metal | 12 | 12 |
| EIH | Powder, Porcelain | 10 | 10 |
| EMA | Cement, Dental | 9 | 9 |
| KLE | Agent, Tooth Bonding, Resin | 5 | 5 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 4 | 4 |
| EJH | Alloy, Metal, Base | 4 | 4 |
| EJJ | Alloy, Amalgam | 4 | 4 |
| EBG | Crown And Bridge, Temporary, Resin | 3 | 3 |
Plus 15 more product codes.
Review panels
- Dental (131)
Most recent Ivoclar North America, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K012174 | ERIS LAYERING MATERIALS | EIH | 2001-08-27 | 46 |
| K011491 | HELIOSEAL CLEAR CHROMA | EBC | 2001-08-16 | 93 |
| K011492 | IN TEN-S | EBF | 2001-07-05 | 51 |
| K011490 | MODIFICATION TO EXCITE | KLE | 2001-06-27 | 43 |
| K011023 | D.SIGN 96 | EJT | 2001-05-02 | 28 |
| K011022 | BIOUNIVERSAL PDF | EJT | 2001-05-02 | 28 |
| K010381 | D.SIGN 30 | EJH | 2001-03-06 | 26 |
| K010250 | TETRIC CERAM HB | EBF | 2001-02-28 | 33 |
| K003293 | EXCITE DSC | KLE | 2001-02-06 | 109 |
| K003407 | SYSTEMP.DESENSITIZER (VIVADENT.DESENSITIZER) | EMA | 2001-01-26 | 86 |
121 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Ivoclar North America, Inc..
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 Vivadent, Inc. (66 510(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 North America, Inc.?
FDA lists 131 510(k) clearances under the applicant name “Ivoclar North America, Inc.” (first 1989, latest 2001), across 25 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ivoclar North America, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ivoclar North America, Inc. is 52 days.
Which FDA product codes appear under Ivoclar North America, Inc.?
The most frequent FDA product codes under this applicant name are EJT (Alloy, Gold-Based Noble Metal, 29); EBF (Material, Tooth Shade, Resin, 28); EJS (Alloy, Other Noble Metal, 12).
Next steps
- See all 131 Ivoclar North America, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EJT, Ivoclar North America, 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.