510(k) Report

FDA applicant

Akervall Technologies, Inc.

Ann Arbor, MI1 decision2012–20120 recalls

FDA records 1 decision for Akervall Technologies, Inc. (Ann Arbor, MI) in 2012: 1 510(k) clearance. All are in product code OBR (Mouthguard, Over-The-Counter). Its devices cite 1 predicate, 0 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

How often FDA has decided Akervall Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2012: 1
2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Akervall Technologies, Inc. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • OBRMouthguard, Over-The-Counter1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 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.

  • K121272Protech DentAkervall Technologies, Inc. · 20123cite it

What has FDA decided for it lately?

  • K121272Protech DentAkervall Technologies, Inc. · 2012

The one decision as Akervall Technologies, Inc. →