510(k) Report

FDA applicant

Sleepcare, LLC

Los Angeles, CA1 decision2026–20260 recalls

FDA records 1 decision for Sleepcare, LLC (Los Angeles, CA) in 2026: 1 510(k) clearance. All are in product code SHI (Impression Material For Fabrication Of…). 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 Sleepcare, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2026

2026 (partial year): 1
2026high 1 (2026)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2026.

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

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Which product codes does it file in?

  • SHIImpression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter1decision

What has FDA decided for it lately?

  • K262421Daybreak Impression MaterialSleepcare, LLC · 2026

The one decision as Sleepcare, LLC →