510(k) Report

FDA applicant

Archtek, Inc.

Austin, TX2 decisions2008–20090 recalls

FDA records 2 decisions for Archtek, Inc. (Austin, TX) from 2008 to 2009: 2 510(k) clearances. Most are in product codes MQC (Mouthguard, Prescription) and OBR (Mouthguard, Over-The-Counter). Its devices cite 3 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

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

FDA decisions per year

1in 2009

2008: 12009: 1
2008high 1 (2008) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Archtek, Inc. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Archtek, Inc.’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, Prescription1decision
  • OBRMouthguard, Over-The-Counter1decision

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K073446Grind GuardArchtek, Inc. · 20082cite it

What has FDA decided for it lately?

  • K090472Grind GuardArchtek, Inc. · 2009
  • K073446Grind GuardArchtek, Inc. · 2008

All 2 as Archtek, Inc. →