510(k) Report

FDA applicant

Microdental, Inc.

Dublin, CA2 decisions2014–20160 recalls

FDA records 2 decisions for Microdental, Inc. (Dublin, CA) from 2014 to 2016: 2 510(k) clearances. Most are in product codes PLC (Sleep Appliances With Patient Monitoring) and LRK (Device, Anti-Snoring). 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

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

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

FDA decisions per year

1in 2016

2014: 12016: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Microdental, Inc. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Microdental, 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?

  • PLCSleep Appliances With Patient Monitoring1decision
  • LRKDevice, Anti-Snoring1decision

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 7 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.

  • K133683MICR02 Osa DeviceMicrodental, Inc. · 20145cite it
  • K161624MicrO2 OSA Device with Micro-RecorderMicrodental, Inc. · 20162cite it

What has FDA decided for it lately?

  • K161624MicrO2 OSA Device with Micro-RecorderMicrodental, Inc. · 2016
  • K133683MICR02 Osa DeviceMicrodental, Inc. · 2014

All 2 as Microdental, Inc. →