Voco GmbH: FDA clearances and approvals
Voco GmbH has 119 FDA 510(k) clearances (first 1991, latest 2026), across 18 product codes in 1 review panel. Median 510(k) review time: 71 days. Since 2017 its median was 101 days, against 126 days for all cleared 510(k)s in the same product codes. openFDA lists 4 product recalls by a recalling firm named Voco GmbH.
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, Voco GmbH's cleared 510(k)s 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 company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Voco GmbH have?
Voco GmbH has 119 FDA 510(k) clearances (first 1991, latest 2026), across 18 product codes in 1 review panel.
How long does FDA take to clear Voco GmbH's 510(k)s?
The median time from FDA receipt to decision across Voco GmbH's cleared 510(k)s is 71 days. Since 2017: 101 days, versus 126 days for all cleared 510(k)s in the same product codes.
What devices does Voco GmbH make?
Its most frequent FDA product codes are EBF (Material, Tooth Shade, Resin, 45); EMA (Cement, Dental, 26); KLE (Agent, Tooth Bonding, Resin, 10).
Has Voco GmbH had device recalls?
openFDA lists 4 product recalls in 3 recall events by a recalling firm whose name matches Voco GmbH; the most recent began 2024-01-25. Recall firm names are matched by name, so related entities filing under other names are not included.
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. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.