510(k) Report

FDA applicant

Amann Girrbach AG

Koblach, AT4 decisions2017–20260 recalls

FDA records 4 decisions for Amann Girrbach AG (Koblach, AT) from 2017 to 2026: 4 510(k) clearances. Most are in product codes EIH (Powder, Porcelain) and MQC (Mouthguard, Prescription). Since 2016 its 510(k)s took a median of 96 days from receipt to decision, against 124 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 1 of them its own earlier devices. No 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 Amann Girrbach AG’s devices, and how often a recall has named them.

FDA decisions per year

2in 2019

2017: 12019: 22026 (partial year): 1
2017high 2 (2019) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Amann Girrbach AG by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • EIHPowder, Porcelain2decisions
  • MQCMouthguard, Prescription1decision
  • EBGCrown And Bridge, Temporary, Resin1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 96 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 124 days; 3 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K171876Ceramill Zolid HT+ whiteAmann Girrbach AG · 20171cites it

What has FDA decided for it lately?

  • K260918Zolid LunarisAmann Girrbach AG · 2026
  • K191836Ceramill A-SplintAmann Girrbach AG · 2019
  • K191843Ceramill A-TempAmann Girrbach AG · 2019
  • K171876Ceramill Zolid HT+ whiteAmann Girrbach AG · 2017

All 4 as Amann Girrbach AG →

Other applicant names beginning “Amann”

FDA records each applicant name separately; these may or may not be the same firm.

Amann Girrbach America, Inc. 1