Zirkonzahn Srl: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Zirkonzahn Srl” (first 2014, latest 2023), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 168 days. Since 2017 the median was 127 days, against 122 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2014 | 1 | 475 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 13 |
| 2019 | 2 | 195 |
| 2020 | 1 | 114 |
| 2021 | 1 | 209 |
| 2022 | 1 | 383 |
| 2023 | 1 | 4 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Zirkonzahn Srl took a median 127 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 122 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EIH | Powder, Porcelain | 4 | 4 |
| EBF | Material, Tooth Shade, Resin | 1 | 1 |
| EBG | Crown And Bridge, Temporary, Resin | 1 | 1 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 1 | 1 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
Review panels
Most recent Zirkonzahn Srl 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232691 | Polibond | EBI | 2023-09-05 | 4 |
| K213722 | ICE Ceramics, ICE Stains, Fresco | EIH | 2022-12-14 | 383 |
| K203765 | ZIRKONZAHN.Implant-Planner, ZIRKONZAHN.Implant-Planner Practice, CAD/CAM STL Converter, CAD/CAM Z-Tray | LLZ | 2021-07-20 | 209 |
| K200676 | ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA | EBG | 2020-07-08 | 114 |
| K190518 | Color Liquid, Vita Liquid | EIH | 2019-11-22 | 263 |
| K183304 | Prettau, ICE, Z-White zirconia blanks | EIH | 2019-04-04 | 127 |
| K181484 | Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral Tissue | EBF | 2018-06-18 | 13 |
| K132230 | ICE ZIRKON TRANSLUZENT | EIH | 2014-11-05 | 475 |
Recalls
openFDA lists no recalls under a recalling firm named Zirkonzahn Srl.
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.
- Zirkonzahn GmbH (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Zirkonzahn Srl?
FDA lists 8 510(k) clearances under the applicant name “Zirkonzahn Srl” (first 2014, latest 2023), across 5 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Zirkonzahn Srl?
The median time from FDA receipt to decision across 510(k)s cleared under the name Zirkonzahn Srl is 168 days. Since 2017: 127 days, versus 122 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Zirkonzahn Srl?
The most frequent FDA product codes under this applicant name are EIH (Powder, Porcelain, 4); EBF (Material, Tooth Shade, Resin, 1); EBG (Crown And Bridge, Temporary, Resin, 1).
Next steps
- See all 8 Zirkonzahn Srl clearances with predicates and recalls
- Run predicate analysis for product code EIH, Zirkonzahn Srl'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.