Vident: FDA filings under this applicant name
FDA lists 36 510(k) clearances under the applicant name “Vident” (first 1990, latest 2007), across 11 product codes in 1 review panel. Median 510(k) review time under this name: 92 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 |
|---|---|---|---|
| EIH | Powder, Porcelain | 16 | 16 |
| DZE | Implant, Endosseous, Root-Form | 7 | 7 |
| EJT | Alloy, Gold-Based Noble Metal | 3 | 3 |
| EJH | Alloy, Metal, Base | 2 | 2 |
| ELW | Material, Impression | 2 | 2 |
| EBF | Material, Tooth Shade, Resin | 1 | 1 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 1 | 1 |
| ELL | Teeth, Porcelain | 1 | 1 |
| ELM | Denture, Plastic, Teeth | 1 | 1 |
| EMA | Cement, Dental | 1 | 1 |
Plus 1 more product codes.
Review panels
- Dental (36)
Most recent Vident 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K063768 | TITANIUM SCALLOPED ABUTMENT | NHA | 2007-06-27 | 189 |
| K060441 | VITA VM 7, MODEL NX77 XXXX, NX78XXXX, NX79 XXXX; VITA VM 8, MODEL VX60 XXXX, VX61 XXXX, VX62 XXXX; VITA VM 9, MODEL NX98 | EIH | 2006-04-27 | 65 |
| K052710 | VITA VM7, MODEL NX77 XXXX, NX78XXXX, NX79 XXXX; VITA VM 8, MODEL VX60 XXXX, VX61 XXXX, VX62 XXXX; VITA VM 9, | EIH | 2006-01-13 | 106 |
| K052130 | VITA IN-CERAM 2000 AL CUBES FOR INLAB, MODELS AL20/AL40 | EIH | 2005-08-15 | 10 |
| K050362 | VITA PM 7 (20 GRAM BOTTLES), VITA PM 7 (50 GRAM BOTTLES) | EIH | 2005-03-15 | 29 |
| K022996 | VITA IN-CERAM YZ CUBES FOR CEREC | EIH | 2002-10-09 | 30 |
| K012473 | VIDENT HEXTOP, SYNOCTA IN-CERAM BLANK/COPING MANUFACTURED BY VIDENT | DZE | 2002-09-11 | 405 |
| K000597 | VITA RESPONSE | EIH | 2000-05-17 | 85 |
| K990367 | PDQ AND PDQ-TI ABUTMENT | DZE | 1999-04-21 | 75 |
| K984198 | WIDE BODY ABUTMENTS | DZE | 1999-02-18 | 86 |
26 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Vident.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Vident?
FDA lists 36 510(k) clearances under the applicant name “Vident” (first 1990, latest 2007), across 11 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 Vident?
The median time from FDA receipt to decision across 510(k)s cleared under the name Vident is 92 days.
Which FDA product codes appear under Vident?
The most frequent FDA product codes under this applicant name are EIH (Powder, Porcelain, 16); DZE (Implant, Endosseous, Root-Form, 7); EJT (Alloy, Gold-Based Noble Metal, 3).
Next steps
- See all 36 Vident clearances with predicates and recalls
- Run predicate analysis for product code EIH, Vident'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.