510(k) Report

FDA applicant

Detax GmbH & Co. KG

Ettingen, DE8 decisions2000–20250 recalls

FDA records 8 decisions for Detax GmbH & Co. KG (Ettingen, DE) from 2000 to 2025: 8 510(k) clearances. Most are in product codes EBI (Resin, Denture, Relining, Repairing, Rebasing) and EBG (Crown And Bridge, Temporary, Resin). Since 2016 its 510(k)s took a median of 131 days from receipt to decision, against 195 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Detax GmbH”.

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 Detax GmbH & Co. KG’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2010: 12017: 12020: 22022: 12023: 12025: 1
2007high 2 (2020) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Detax GmbH & Co. KG by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Detax GmbH & Co. KG’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?

  • EBIResin, Denture, Relining, Repairing, Rebasing3decisions
  • EBGCrown And Bridge, Temporary, Resin2decisions
  • MQCMouthguard, Prescription1decision
  • EBFMaterial, Tooth Shade, Resin1decision
  • EMACement, Dental1decision

How long do its 510(k) reviews take?

Since 2016, its 6 510(k)s took a median of 131 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 195 days; 4 of its 6 were faster than that.

Whose devices does it build on?

Its devices cite 7 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 1 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.

  • K200461Freeprint dentureDetax GmbH & Co. KG · 20203cite it
  • K222877FREEPRINT crownDetax GmbH · 20222cite it
  • K200273FREEPRINT tempDetax GmbH & Co. KG · 20201cites it

What has FDA decided for it lately?

  • K252430Freeprint® denture flexDetax GmbH · 2025
  • K232448FREEPRINT® splintmasterDetax GmbH · 2023
  • K222877FREEPRINT crownDetax GmbH · 2022
  • K200461Freeprint dentureDetax GmbH & Co. KG · 2020
  • K200273FREEPRINT tempDetax GmbH & Co. KG · 2020
  • K162654mollosil plusDetax GmbH & Co. KG · 2017
  • K100247Detax Implantlink SemiDetax GmbH & Co. KG · 2010
  • K994012Tempofit, Model 02693Detax GmbH & Co. KG · 2000

All 5 as Detax GmbH & Co. KG →All 3 as Detax GmbH →