Company ยท DE
Envisiontec GmbH
FDA 510(k) clearances and medical device recalls filed under this name, 2020 to 2022. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|
| MQC | Mouthguard, Prescription | 2 |
| EBF | Material, Tooth Shade, Resin | 1 |
| EBG | Crown And Bridge, Temporary, Resin | 1 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|
| Jun 10, 2022 | K220894 | SmileGuard Envisiontec GmbH, DE | MQC |
| Jun 14, 2021 | K211101 | E-Temp Envisiontec GmbH, DE | EBG |
| May 25, 2021 | K210977 | E-Dent 1000 Envisiontec GmbH, DE | EBF |
| Mar 30, 2021 | K203641 | E-Denture Pro Envisiontec GmbH, DE | EBI |
| Nov 27, 2020 | K201173 | E-Guard Envisiontec GmbH, DE | MQC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|
| No recalls in this window. |