510(k) Report

FDA applicant

Rls Global AB

Molndal1 decision2001–20010 recalls

FDA records 1 decision for Rls Global AB (Molndal) in 2001: 1 original PMA approval. All are in product code LMW (Solution, Removal, Carries). 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 Rls Global AB’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Rls Global AB since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Rls Global AB by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LMWSolution, Removal, Carries1decision

What has FDA decided for it lately?

  • P000005Carisolv Non-Invasive Dental Caries Removal SystemRls Global AB · 2001

The one decision as Rls Global AB →