510(k) Report

FDA applicant

Envisiontec GmbH

Gladbeck, DE5 decisions2020–20221 recall

FDA records 5 decisions for Envisiontec GmbH (Gladbeck, DE) from 2020 to 2022: 5 510(k) clearances. Most are in product codes MQC (Mouthguard, Prescription) and EBG (Crown And Bridge, Temporary, Resin). Since 2016 its 510(k)s took a median of 74 days from receipt to decision, against 178 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 0 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Envisiontec GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2020: 12021: 32022: 1
2020high 3 (2021) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

1in 2022

2022: 1
2020high 1 (2022) · low 0 (2020)2026

Class I Class II/III not classified

FIG. 1 — Envisiontec GmbH by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Envisiontec GmbH’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • MQCMouthguard, Prescription2decisions
  • EBGCrown And Bridge, Temporary, Resin1decision
  • EBFMaterial, Tooth Shade, Resin1decision
  • EBIResin, Denture, Relining, Repairing, Rebasing1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 74 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 178 days; 3 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K210977E-Dent 1000Envisiontec GmbH · 20213cite it
  • K211101E-TempEnvisiontec GmbH · 20212cite it
  • K201173E-GuardEnvisiontec GmbH · 20202cite it
  • K203641E-Denture ProEnvisiontec GmbH · 20211cites it

What has FDA decided for it lately?

  • K220894SmileGuardEnvisiontec GmbH · 2022
  • K211101E-TempEnvisiontec GmbH · 2021
  • K210977E-Dent 1000Envisiontec GmbH · 2021
  • K203641E-Denture ProEnvisiontec GmbH · 2021
  • K201173E-GuardEnvisiontec GmbH · 20201 recall

All 5 as Envisiontec GmbH →

What has been recalled?

1 recall linked to its devices; the latest:

  • K201173PCA 4000 Curing Units, SKU number ACC-06-1000 The PCA 4000 is used for curing industrial…Jan 20, 2022Class II