Zhermack Dental Production: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Zhermack Dental Production” (first 1994, latest 1995), across 1 product code in 1 review panel. Median 510(k) review time under this name: 315 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 |
|---|---|---|---|
| ELW | Material, Impression | 11 | 11 |
Review panels
- Dental (11)
Most recent Zhermack Dental Production 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K935892 | INDURENT GEL | ELW | 1995-10-17 | 735 |
| K935890 | ZETAPLUS (PUTTY) | ELW | 1995-09-08 | 696 |
| K935898 | HYDROGUM | ELW | 1995-08-22 | 679 |
| K935896 | THIXOFLEX | ELW | 1994-09-09 | 332 |
| K935889 | OCCLUFAST | ELW | 1994-08-23 | 315 |
| K935888 | ELITE FAST LIGHT BODY | ELW | 1994-08-23 | 315 |
| K935887 | ELITE REGULAR BODY | ELW | 1994-08-23 | 315 |
| K935886 | ELITE LIGHT BODY | ELW | 1994-08-23 | 315 |
| K935885 | ELITE FAST PUTTY SOFT | ELW | 1994-08-23 | 315 |
| K935884 | ELITE PUTTY SOFT | ELW | 1994-08-23 | 315 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Zhermack Dental Production.
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.
- Zhermack S.P.A. (19 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Zhermack Dental Production?
FDA lists 11 510(k) clearances under the applicant name “Zhermack Dental Production” (first 1994, latest 1995), across 1 product code 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 Zhermack Dental Production?
The median time from FDA receipt to decision across 510(k)s cleared under the name Zhermack Dental Production is 315 days.
Which FDA product codes appear under Zhermack Dental Production?
The most frequent FDA product codes under this applicant name are ELW (Material, Impression, 11).
Next steps
- See all 11 Zhermack Dental Production clearances with predicates and recalls
- Run predicate analysis for product code ELW, Zhermack Dental Production'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.