Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in GermanyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Desktop MetalLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list EnvisionTEC with 5 510(k) clearances. The most recent is a 510(k) clearance dated Jun 10, 2022: SmileGuard.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Jun 10, 2022 | SmileGuardK220894 · MQC | 510(k) clearances |
| Jun 14, 2021 | E-TempK211101 · EBG | 510(k) clearances |
| May 25, 2021 | E-Dent 1000K210977 · EBF | 510(k) clearances |
| Mar 30, 2021 | E-Denture ProK203641 · EBI | 510(k) clearances |
| Nov 27, 2020 | E-GuardK201173 · MQC | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
