510(k) Report

FDA applicant

Oralabs, Inc.

Parker, CO2 decisions2012–20190 recalls

FDA records 2 decisions for Oralabs, Inc. (Parker, CO) from 2012 to 2019: 2 510(k) clearances. Most are in product codes LFD (Saliva, Artificial) and OBR (Mouthguard, Over-The-Counter). Its devices cite 2 predicates, 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 Oralabs, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2012: 12019: 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 — Oralabs, 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?

  • LFDSaliva, Artificial1decision
  • OBRMouthguard, Over-The-Counter1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K113326Oral B Plus Outlast Night Time Dental GuardOralabs, Inc. · 20122cite it

What has FDA decided for it lately?

  • K181839CVS Health Dry Mouth Spray, OraLabs Dry Mouth SprayOralabs, Inc. · 2019
  • K113326Oral B Plus Outlast Night Time Dental GuardOralabs, Inc. · 2012

All 2 as Oralabs, Inc. →