Merz Dental GmbH: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Merz Dental GmbH” (first 2003, latest 2017), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 80 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 | 102 |
| 2013 | 1 | 220 |
| 2014 | 2 | 139 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 80 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Merz Dental GmbH took a median 80 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 126 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EBG | Crown And Bridge, Temporary, Resin | 3 | 3 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 2 | 2 |
| ELM | Denture, Plastic, Teeth | 2 | 2 |
| EBF | Material, Tooth Shade, Resin | 1 | 1 |
| MQC | Mouthguard, Prescription | 1 | 1 |
Review panels
- Dental (9)
Most recent Merz Dental GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K173124 | PEEK Biosolution | EBF | 2017-12-18 | 80 |
| K140758 | M-PM-DISC (PINK) | EBI | 2014-09-15 | 173 |
| K134015 | M-PM-DISC | MQC | 2014-04-11 | 105 |
| K130076 | PROMOLUX, PROMOLUX HI, WEROPRESS, PREMECO PCS | EBI | 2013-08-22 | 220 |
| K120404 | MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETH | ELM | 2012-05-21 | 102 |
| K080556 | ARTBLOC TEMP, DIMENSION: 15.5 X19.39 MM V-CLASSIC SHADES AND BLEACH SHADES | EBG | 2008-05-02 | 64 |
| K071548 | WIELAND ZENO CAO TEMPORARY PMMA DISC, TOOTH-COLORED | EBG | 2007-08-21 | 76 |
| K061809 | ARTEGRAL IMCROWN | EBG | 2006-09-13 | 78 |
| K030588 | ARTEGRAL AND POLYSTAR SELECTION | ELM | 2003-05-07 | 71 |
Recalls
openFDA lists no recalls under a recalling firm named Merz Dental GmbH.
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.
- Merz North America, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Merz Dental GmbH?
FDA lists 9 510(k) clearances under the applicant name “Merz Dental GmbH” (first 2003, latest 2017), across 5 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 Merz Dental GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Merz Dental GmbH is 80 days.
Which FDA product codes appear under Merz Dental GmbH?
The most frequent FDA product codes under this applicant name are EBG (Crown And Bridge, Temporary, Resin, 3); EBI (Resin, Denture, Relining, Repairing, Rebasing, 2); ELM (Denture, Plastic, Teeth, 2).
Next steps
- See all 9 Merz Dental GmbH clearances with predicates and recalls
- Run predicate analysis for product code EBG, Merz Dental GmbH'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.