Voco GmbH: FDA filings under this applicant name
FDA lists 119 510(k) clearances under the applicant name “Voco GmbH” (first 1991, latest 2026), across 18 product codes in 1 review panel. Median 510(k) review time under this name: 71 days. Since 2017 the median was 101 days, against 126 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 |
|---|---|---|
| 2012 | 2 | 46 |
| 2013 | 2 | 145 |
| 2014 | 3 | 186 |
| 2015 | 4 | 98 |
| 2016 | 5 | 238 |
| 2017 | 3 | 108 |
| 2018 | 2 | 91 |
| 2019 | 2 | 76 |
| 2020 | 5 | 54 |
| 2021 | 1 | 73 |
| 2022 | 3 | 172 |
| 2023 | 3 | 105 |
| 2024 | 0 | — |
| 2025 | 2 | 44 |
| 2026 | 3 | 214 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Voco GmbH took a median 101 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 |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | 45 | 45 |
| EMA | Cement, Dental | 26 | 26 |
| KLE | Agent, Tooth Bonding, Resin | 10 | 10 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 8 | 8 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 5 | 5 |
| EBG | Crown And Bridge, Temporary, Resin | 5 | 5 |
| EJK | Liner, Cavity, Calcium Hydroxide | 4 | 4 |
| ELW | Material, Impression | 3 | 3 |
| LBH | Varnish, Cavity | 3 | 3 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | 2 | 2 |
Plus 8 more product codes.
Review panels
- Dental (119)
Most recent Voco GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252073 | VOCO Profluorid Varnish + BioMin | LBH | 2026-05-01 | 303 |
| K261357 | Grandio disc multicolor | EBF | 2026-04-27 | 3 |
| K252606 | Bifix Veneer LC, Bifix Veneer Try-In | EMA | 2026-03-20 | 214 |
| K251390 | MTA vpt | KIF | 2025-07-03 | 59 |
| K251239 | GrandioSO Unlimited | EBF | 2025-05-21 | 29 |
| K231817 | AlignerFlow LC | DYH | 2023-12-01 | 163 |
| K231591 | V-Print c&b temp | POW | 2023-07-31 | 60 |
| K230877 | Admira Fusion 5 | EBF | 2023-07-13 | 105 |
| K220236 | V-Print dentbase | EBI | 2022-09-21 | 237 |
| K220640 | Bifix Hybrid Abutment Cement | EMA | 2022-08-23 | 172 |
109 earlier clearances. See the full list in Caduvo.
Recalls
4 product recalls in 3 recall events; 2 initiated in the last five years. Most recent: 2024-01-25.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Voco GmbH?
FDA lists 119 510(k) clearances under the applicant name “Voco GmbH” (first 1991, latest 2026), across 18 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 Voco GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Voco GmbH is 71 days. Since 2017: 101 days, versus 126 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Voco GmbH?
The most frequent FDA product codes under this applicant name are EBF (Material, Tooth Shade, Resin, 45); EMA (Cement, Dental, 26); KLE (Agent, Tooth Bonding, Resin, 10).
Next steps
- See all 119 Voco GmbH clearances with predicates and recalls
- Run predicate analysis for product code EBF, Voco 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.