Envisiontec GmbH: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Envisiontec GmbH” (first 2020, latest 2022), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 74 days. Since 2017 the median was 74 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 |
|---|---|---|
| 2020 | 1 | 210 |
| 2021 | 3 | 62 |
| 2022 | 1 | 74 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Envisiontec GmbH took a median 74 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 |
|---|---|---|---|
| MQC | Mouthguard, Prescription | 2 | 2 |
| EBF | Material, Tooth Shade, Resin | 1 | 1 |
| EBG | Crown And Bridge, Temporary, Resin | 1 | 1 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 1 | 1 |
Review panels
- Dental (5)
Most recent Envisiontec GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K220894 | SmileGuard | MQC | 2022-06-10 | 74 |
| K211101 | E-Temp | EBG | 2021-06-14 | 62 |
| K210977 | E-Dent 1000 | EBF | 2021-05-25 | 54 |
| K203641 | E-Denture Pro | EBI | 2021-03-30 | 106 |
| K201173 | E-Guard | MQC | 2020-11-27 | 210 |
Recalls
openFDA lists no recalls under a recalling firm named Envisiontec 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Envisiontec GmbH?
FDA lists 5 510(k) clearances under the applicant name “Envisiontec GmbH” (first 2020, latest 2022), across 4 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 Envisiontec GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Envisiontec GmbH is 74 days. Since 2017: 74 days, versus 126 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Envisiontec GmbH?
The most frequent FDA product codes under this applicant name are MQC (Mouthguard, Prescription, 2); EBF (Material, Tooth Shade, Resin, 1); EBG (Crown And Bridge, Temporary, Resin, 1).
Next steps
- See all 5 Envisiontec GmbH clearances with predicates and recalls
- Run predicate analysis for product code MQC, Envisiontec 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.