Ivoclar USA, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Ivoclar USA, Inc.” (first 1984, latest 2001), across 8 product codes in 1 review panel. Median 510(k) review time under this name: 70 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 |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | 2 | 2 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 2 | 2 |
| ELM | Denture, Plastic, Teeth | 2 | 2 |
| EBG | Crown And Bridge, Temporary, Resin | 1 | 1 |
| EBH | Material, Impression Tray, Resin | 1 | 1 |
| EIH | Powder, Porcelain | 1 | 1 |
| EJS | Alloy, Other Noble Metal | 1 | 1 |
| EJT | Alloy, Gold-Based Noble Metal | 1 | 1 |
Review panels
- Dental (11)
Most recent Ivoclar USA, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K012877 | HIGH GOLD PALLADIUM FREE CERAMIC SOLDER | EJT | 2001-11-21 | 86 |
| K981264 | ARISTON PHC | EBF | 1998-07-02 | 86 |
| K980986 | PROCAD | EIH | 1998-05-11 | 55 |
| K941849 | PROVIPONT C&B | EBG | 1994-08-17 | 125 |
| K923644 | DW243-64 | EJS | 1992-11-04 | 106 |
| K864708 | SR 3/60 NF DENTURE MATER. & SELF-CURE DENT. RESIN | EBI | 1987-02-25 | 85 |
| K864710 | ISOSIT N | EBF | 1987-02-10 | 70 |
| K864709 | IVOCRYL HEAT CURE & IVOCRYL QUICK DENTURE MATERIAL | EBI | 1987-02-10 | 70 |
| K864707 | SR-VIVODENT ANTERIOR & SR-ORTHOTYP POSTERIOR TEETH | ELM | 1987-02-10 | 70 |
| K863421 | SR-IVOLEN TRAY MATERIAL | EBH | 1986-11-03 | 60 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Ivoclar USA, 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 North America, Inc. (131 510(k)s)
- Ivoclar Vivadent, Inc. (66 510(k)s)
- Ivoclar Vivadent, AG (31 510(k)s)
- Ivoclar Vivadent, Agin (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ivoclar USA, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Ivoclar USA, Inc.” (first 1984, latest 2001), across 8 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 USA, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ivoclar USA, Inc. is 70 days.
Which FDA product codes appear under Ivoclar USA, Inc.?
The most frequent FDA product codes under this applicant name are EBF (Material, Tooth Shade, Resin, 2); EBI (Resin, Denture, Relining, Repairing, Rebasing, 2); ELM (Denture, Plastic, Teeth, 2).
Next steps
- See all 11 Ivoclar USA, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EBF, Ivoclar USA, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.