Wieland Dental + Technik GmbH & Co. KG: FDA filings under this applicant name
FDA lists 45 510(k) clearances under the applicant name “Wieland Dental + Technik GmbH & Co. KG” (first 2002, latest 2015), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 53 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 | 1 | 119 |
| 2014 | 0 | — |
| 2015 | 3 | 139 |
| 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 |
|---|---|---|---|
| EJT | Alloy, Gold-Based Noble Metal | 23 | 23 |
| EIH | Powder, Porcelain | 14 | 14 |
| EJS | Alloy, Other Noble Metal | 5 | 5 |
| EBG | Crown And Bridge, Temporary, Resin | 1 | 1 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 1 | 1 |
| EMA | Cement, Dental | 1 | 1 |
Review panels
- Dental (45)
Most recent Wieland Dental + Technik GmbH & Co. KG 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K152118 | Zenostar MT, Zenostar Color Liquids | EIH | 2015-12-16 | 139 |
| K151142 | IVOBASE CAD FOR ZENOTEC, IVOBASE CAD BOND, IVOBASE CAD MODELLING LIQUID | EBI | 2015-08-13 | 106 |
| K142233 | zenostar MO, Zenostar T, Zenostar VisualiZr | EIH | 2015-01-05 | 145 |
| K130184 | ZENOLUX | EIH | 2013-05-24 | 119 |
| K112710 | ZENOTEC ZR BRIDGE, ZENOSTAR ZR TRANSLUCENT, ZENOTEC COLOR ZR, ZENOSTAR COLOR ZR | EIH | 2011-10-17 | 28 |
| K103773 | ZENOFLEX DIMENSION | EIH | 2011-03-16 | 79 |
| K103494 | ZENOSTAR MAGIC GLAZE | EIH | 2011-02-16 | 79 |
| K082257 | ZENO AI ECO DISC | EIH | 2008-09-18 | 41 |
| K080182 | ZENO PMMA DISC | EBG | 2008-04-08 | 74 |
| K073108 | ZENO ZR DISC | EIH | 2007-11-21 | 19 |
35 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Wieland Dental + Technik GmbH & Co. KG.
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.
- Wieland Edelmetalle GmbH & Co. (14 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Wieland Dental + Technik GmbH & Co. KG?
FDA lists 45 510(k) clearances under the applicant name “Wieland Dental + Technik GmbH & Co. KG” (first 2002, latest 2015), across 6 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 Wieland Dental + Technik GmbH & Co. KG?
The median time from FDA receipt to decision across 510(k)s cleared under the name Wieland Dental + Technik GmbH & Co. KG is 53 days.
Which FDA product codes appear under Wieland Dental + Technik GmbH & Co. KG?
The most frequent FDA product codes under this applicant name are EJT (Alloy, Gold-Based Noble Metal, 23); EIH (Powder, Porcelain, 14); EJS (Alloy, Other Noble Metal, 5).
Next steps
- See all 45 Wieland Dental + Technik GmbH & Co. KG clearances with predicates and recalls
- Run predicate analysis for product code EJT, Wieland Dental + Technik GmbH & Co. KG'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.