Vita Zahnfabrik H.Rauter GmbH & Co.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Vita Zahnfabrik H.Rauter GmbH & Co.” (first 2009, latest 2025), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 133 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 | 1 | 136 |
| 2013 | 0 | — |
| 2014 | 1 | 212 |
| 2015 | 1 | 131 |
| 2016 | 1 | 192 |
| 2017 | 0 | — |
| 2018 | 1 | 135 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 63 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Vita Zahnfabrik H.Rauter GmbH & Co. took a median 99 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 138 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EIH | Powder, Porcelain | 6 | 6 |
| EBF | Material, Tooth Shade, Resin | 1 | 1 |
| NHA | Abutment, Implant, Dental, Endosseous | 1 | 1 |
Review panels
- Dental (8)
Most recent Vita Zahnfabrik H.Rauter GmbH & Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243940 | VITA YZ Multi Translucent | EIH | 2025-02-21 | 63 |
| K180703 | VITA YZ ST and VITA YZ XT | EIH | 2018-08-01 | 135 |
| K153645 | VITA ENAMIC Implant Solutions (IS) | NHA | 2016-06-30 | 192 |
| K152373 | VITA VM LC Flow | EBF | 2015-12-30 | 131 |
| K132070 | VITA SUPRINITY(R) | EIH | 2014-01-31 | 212 |
| K122269 | ENAMIC | EIH | 2012-12-13 | 136 |
| K102128 | VITABLOCS | EIH | 2010-08-11 | 13 |
| K090644 | VITABLOCS, MODEL VX55-**** | EIH | 2009-03-31 | 21 |
Recalls
openFDA lists no recalls under a recalling firm named Vita Zahnfabrik H.Rauter GmbH & Co..
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.
- Vita Zahnfabrik GmbH H Rauter & CO (3 510(k)s)
- Vita Zahnfabrik H. Rauter GmbH & Co. Kg. (2 510(k)s)
- Vita (1 510(k)s)
- Vita Dental Co. (1 510(k)s)
- Vita Medics (1 510(k)s)
- Vita Zanhnfabrik H. Rauter GmbH Co. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Vita Zahnfabrik H.Rauter GmbH & Co.?
FDA lists 8 510(k) clearances under the applicant name “Vita Zahnfabrik H.Rauter GmbH & Co.” (first 2009, latest 2025), across 3 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 Vita Zahnfabrik H.Rauter GmbH & Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Vita Zahnfabrik H.Rauter GmbH & Co. is 133 days.
Which FDA product codes appear under Vita Zahnfabrik H.Rauter GmbH & Co.?
The most frequent FDA product codes under this applicant name are EIH (Powder, Porcelain, 6); EBF (Material, Tooth Shade, Resin, 1); NHA (Abutment, Implant, Dental, Endosseous, 1).
Next steps
- See all 8 Vita Zahnfabrik H.Rauter GmbH & Co. clearances with predicates and recalls
- Run predicate analysis for product code EIH, Vita Zahnfabrik H.Rauter GmbH & Co.'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.